2A7QE-9100Opto-acoustic imaging device

Imagio® Breast Imaging System Operator Manual MKTG 1100 Rev. 1.3 IDE study device, not approved in the United States 1 Imagio® Breast Imaging System Model 9100 Operator/User Manual for use with probe models 8101 and 8001 Imagio® Breast Imaging System Operator Manual LBLG-00000111 Imagio Breast Imaging System Operator Manual 2 I About Seno Medical Instruments™ Seno Medical Instruments™ is a medical device company focused on the detection of cancer using its patented Opto-acoustic (OA) technology. Opto-acoustic (OA) imaging combines light and sound to produce functional images. Legal Manufacturer Seno Medical Instruments, Inc. 8023 Vantage Dr. Ste 1000 San Antonio, TX 78230-4726 Tel: 210-615-6501 Seno Medical Service Tel: 888-978-8835 Email: [email protected] Caution: Rx Only in the United States (Federal law restricts this device to sale by or on the order of a physician). www.senomedical.com https://senomedical.com/patents/ All materials contained in this document are protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, published, or broadcast without the prior written permission of Seno Medical Instruments, Inc., or in the case of third-party materials, the owner of that content. You may not alter or remove any trademark, copyright, or other notice from copies of the content. Imagio® System, Imagio® Breast Imaging System, Imagio® OA/US Breast Imaging System, SenoGram® and Seno Medical® are registered trademarks of ©2022 Seno Medical Instruments, Inc. ©2022 Hologic Inc., All rights reserved. Hologic, SuperSonic, MACH, ShearWave and associated logos are trademarks and /or registered trademarks of Supersonic Imagine, Hologic, Inc., and /or its subsidiaries in the United States, Europe and other countries. This information is intended for medical professionals in the U.S. and other markets and is not intended as a product solicitation or promotion where such activities are prohibited. Imagio® Breast Imaging System Operator Manual LBLG-00000111 Imagio Breast Imaging System Operator Manual 3 Table of Contents I About Seno Medical Instruments™ ........................................................................................................... 2 II Statements ............................................................................................................................................. 7 1 System Overview ................................................................................................................................... 9 1.1 Documentation Access ......................................................................................................................................... 9 1.2 Overview .............................................................................................................................................................. 9 1.3 Who Should Use This Manual? ............................................................................................................................. 9 1.4 Risk Management To Medical Devices ...............................................................................................................10 1.5 Safety, EMC, and Regulatory Compliance...........................................................................................................10 2 Imagio® Breast Imaging System ........................................................................................................... 19 2.1 Device Description .............................................................................................................................................19 2.2 Indications for Use .............................................................................................................................................19 2.3 Intended Use ......................................................................................................................................................19 2.4 Probe Intended Use and Indications ..................................................................................................................20 2.5 Components .......................................................................................................................................................22 2.6 Compatible Accessories and Kits ........................................................................................................................25 3 Scan Room and the Imagio® Breast ........................................................................................................ 26 3.1 The Imagio® Breast Imaging System Heating .....................................................................................................26 3.2 Positioning the Imagio® Breast Imaging System .................................................................................................26 3.3 Probe Storage/Transportation ...........................................................................................................................26 3.4 Moving the Imagio® Breast Imaging System ......................................................................................................27 3.5 Positions of Operator, Patient, and Individuals in the Scan Room ......................................................................27 3.6 Confirm Laser Safety Items ................................................................................................................................27 3.7 Ensure Proper Environmental Operating Conditions..........................................................................................28 4 Probes ................................................................................................................................................ 38 4.1 Probe/Clinical Applications Compatibility ...........................................................................................................3…

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8023 Vantage Drive, 10 th Floor, Suite 1000 • San Antonio, TX 78230 Office: 210.615.6501 • Fax: 210.615.6508 www.senomedical.com July 29, 2022 Eurofins Electrical and Electronic Testing NA, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 RE: LETTER OF AGENT AUTHORIZATION To Whom It May Concern: We, the undersigned, hereby authorize Harmanpreet Pannu of Eurofins Electrical and Electronic Testing North America, Inc., to act on behalf of Seno Medical Instruments, Inc. in all matters relating to further application for FCC and/or RED equipment authorization, including the signing of all documents relating to these matters. We als o hereby certify that no party to the application authorized hereunder is subject to the denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C.853(a). This agreement expires on 29July2023. Sincerely, Tom Umbel Ann Waterhouse, RAC-Devices CEO VP, RA/QA Signature: Email: Tom Umbel [email protected] agent authorization request29jULY2022 Final Audit Report2022-07-29 Created:2022-07-29 By:Ann Waterhouse ([email protected]) Status:Signed Transaction ID:CBJCHBCAABAAAWUAY5Ht2kBlqxs-7EKsiNKepbDeOIy8 "agent authorization request29jULY2022" History Document created by Ann Waterhouse ([email protected]) 2022-07-29 - 8:07:11 PM GMT- IP address: 98.97.83.35 Document emailed to Catherine Martin ([email protected]) for signature 2022-07-29 - 8:07:43 PM GMT Email viewed by Catherine Martin ([email protected]) 2022-07-29 - 8:08:27 PM GMT- IP address: 104.47.58.254 Document e-signed by Catherine Martin ([email protected]) Signature Date: 2022-07-29 - 8:09:28 PM GMT - Time Source: server- IP address: 75.1.141.198 Agreement completed. 2022-07-29 - 8:09:28 PM GMT

August 18, 2022 Eurofins Electrical and Electronic Testing NA, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 RE: CONFIDENTIALITY REQUEST FOR Imagio 9100, FCC ID# 2A7QE-9100 To Whom It May Concern: This letter serves as an official request for confidentiality under sections 0.457 and 0.459 of CFR 47. We have requested that the system schematics and RFID schematics required to be submitted with this application be permanently withheld from public review. These documents contain detailed system and equipment descriptions and related information about the product, which Seno Medical Instruments considers to be proprietary, confidential, and a custom design and otherwise, would not release to the general public. Since this design is a basis from which future technological products will evolve, Seno Medical Instruments feels that this information would be of benefit to its competitors, and that the disclosure of the information in these documents would give our competitors an unfair advantage in the market. Please contact me if there is any information you may need. Sincerely, Ann Waterhouse VP QA/RA

August 18, 2022 Eurofins Electrical and Electronic Testing NA, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 RE: Short Term Confidentiality Request For Imagio9100, FCC ID#: 2A7QE-9100 To Whom It May Concern: In accordance with sections 0.457 and 0.459 of CFR 47, Seno Medical Instruments requests short-term Confidentiality of following sections of this application for a period of 45 days after grant is issued. Test setup photos External photos Internal photos User’s manual These documents contain detailed system and equipment descriptions and related information about the product, which Seno Medical Instruments considers to be proprietary, confidential, and a custom design and otherwise, would not release to the general public. Since this design is a basis from which future technological products will evolve, Seno Medical Instruments feels that this information would be of benefit to its competitors, and that the disclosure of the information in these documents would give our competitors an unfair advantage in the market. Please contact me if there is any information you may need. Sincerely, Ann Waterhouse VP QA/RA

Label close up: Left side internal lower: Left side internal upper: Left side under skin: Left side with skin: NFC Card in console: Q-switch location: Rear skin with label: Right view of console and monitor Right side internal lower: Right side internal upper: Right side under skin Right side with skin Console and monitor Top body under skin

54321678 D C B A D C B A 54321678 Sheet 1 of 1 TITLE DWG. NO.REV. DRAWN IN VISIOSCALE: N/A Label, Imagio Nameplate LBLG-00000115 4 UNLESS OTHERWISE SPECIFIED PROPRIETARY AND CONFIDENTIAL THE INFO RMATIO N CONTAINED IN THIS DRAWING IS THE SO LE PROP ER TY O F SENO MEDICAL INSTRUMENTS. ANY REPR ODUCTIO N IN PAR T O R AS A WHOL E W ITHO UT THE WR ITTEN P ER MISSION O F SENO MEDICAL INSTR UMENTS IS PROHIB ITED. N/A N/A FINISH DIMENSIONAL UNITS: INCHES TOL ER AN CES FRACTIONAL +/- 1/32 ANGULAR: MACH +/- ½ DEGREE ONE DECIMAL PLACE +/- 0.1 TWO DECIMAL PLACES +/- 0.06 THREE DECIMAL PLACES +/- 0.005 Previo us num ber 0.007" Thk Polycarbonate N/A MATER IAL Made From Part No. V. Pacheco Drawn B y NOTES : 1. Use 3M adhesive 467MP or 9667MP. 2. Subsurface printing onl y. 3. Background i s white. 4. Match colors of graphics with provided graphic file. 5. One label per lot is to be inspected. Denotes Incoming Inspection dimensions . 6. Perform inspection using S ID-0000000212. 7. A Certificate of Conformance and RoHS statement is required for the material. All material must be RoHS compliant X.X Seno Medical Instruments, Inc. 8023 Vantage Drive, Suite 1000 San Antonio, TX 78230 USA www.senomedical.com CISPR11 Group 1 Class A IP20 500 lb 227 kg Complies with 21 CF R 1040.10 and 1040.11 except for conf ormance with IEC 60825-1 Ed. 3 and IEC 60601- 2-22 Ed. 3.1, as described in Laser Notice No. 56, dated May 8, 2019 ECREPECREP Rx Only 4.5 5.8 4X R 0.13 REF LBLG-00000115 0.43 REF1.29 REF 0.20 REF Kiss-cut tab La bel edge Boarder Key Kiss-cut tab La bel edge Boarder Key 208-240 VAC 50/60Hz 10A 208-240 VAC 50/60Hz 10A 9100 Imagio ® Imagio ® 5013988 REVISION HISTORY REV 1 2 DESCRIPTION INITIAL RELEASE UPD ATED REF NUMBER DATE 10/27/2020 2/5/2021 3 REMOVED DUPLICATE VOLTAGE INFO, ADDED IP RATING NUMBER , UPD ATE TOLER ANCES 4/7/2021 4 REMOVED CE MARK AND EMERGO EUROPE INFORMATION -- 07-21 REDLINE 7/7/22 07-22 FCC ID: 2A7QEX-9100 5

54321678 D C B A D C B A 54321678 Sheet 1 of 1 TITLE DWG. NO.REV. DRAWN IN VISIOSCALE: N/A Label, Imagio Nameplate LBLG-00000115 6 UNLESS OTHERWISE SPECIFIED PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF SENO MEDICAL INSTRUMENTS. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF SENO MEDICAL INSTRUMENTS IS PROHIBITED. N/A N/A FINISH DIMENSIONAL UNITS: INCHES TOLERANCES FRACTIONAL +/- 1/32 ANGULAR: MACH +/- ½ DEGREE ONE DECIMAL PLACE +/- 0.1 TWO DECIMAL PLACES +/- 0.06 THREE DECIMAL PLACES +/- 0.005 Previous number 0.007" Thk Polycarbonate N/A MATERIAL Made From Part No. V. Pacheco Drawn By NOTES: 1. Use 3M adhesive 467MP or 9667MP. 2. Subsurface printing only. 3. Background is white. 4. Match colors of graphics with provided graphic file. 5. One label per lot is to be inspected. Denotes Incoming Inspection dimensions. 6. Perform inspection using SID-0000000212. 7. A Certificate of Conformance and RoHS statement is required for the material. All material must be RoHS compliant X.X Seno Medical Instruments, Inc. 8023 Vantage Drive, Suite 1000 San Antonio, TX 78230 USA www.senomedical.com CISPR11 Group 1 Class A IP20 500 lb 227 kg Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3 and IEC 60601- 2-22 Ed. 3.1, as described in Laser Notice No. 56, dated May 8, 2019 ECREP Rx Only 4.5 5.8 4X R 0.13 REF LBLG-00000115 0.43 REF1.29 REF 0.20 REF Kiss-cut tab Label edge Boarder Key Kiss-cut tab Label edge Boarder Key 208-240 VAC 50/60Hz 10A 208-240 VAC 50/60Hz 10A 9100 Imagio ® Imagio ® 5013988 REVISION HISTORY REV 1 2 DESCRIPTION INITIAL RELEASE UPDATED REF NUMBER DATE 10/27/2020 2/5/2021 3 REMOVED DUPLICATE VOLTAGE INFO, ADDED IP RATING NUMBER, UPDATE TOLERANCES 4/7/2021 4 REMOVED CE MARK AND EMERGO EUROPE INFORMATION 6/29/2021 07-22 2460 FCC ID: 2A7QE-9100 5 6 ADDED FCC MARK AND ID ADDED CE MARK AND EMERGO EUROPE INFORMATION -- -- DRAFT

HEADQUARTERS: 914 WEST PATAPSCO AVENUE • BALTIMORE, MARYLAND 21230 • PHONE (410) 354-3300 • FAX (410) 354-3313 Maryland | California | Texas | China | Korea | Taiwan www.metlabs.com 9/14/2022 Seno Medical Instruments Inc. Alfredo Ramirez 8023 Vantage Dr., Ste. 1000 San Antonio, TX 78230 Dear Alfredo Ramirez, Enclosed is the EMC test report for compliance testing of Seno Medical instruments Inc., Imagio 9100 (Model: 9100), tested to the requirements of: • Title 47 of the CFR, Part 15.225, Subpart C for Certification as an Intentional Radiator. • RSS-210: Issue 10, License-Exempt Radio Apparatus: Category 1 Equipment Thank you for using the services of Eurofins E&E North America. If you have any questions regarding these results or if we can be of further service to you, please feel free to contact me. Sincerely, Nancy LaBrecque Documentation Department Eurofins Electrical and Electronic Testing NA, Inc. Reference: WIR120126-FCC15.225_RSS-210_R1 Certificates and reports shall not be reproduced except in full, without the written permission of Eurofins E&E North America While use of the A2LA logo in this report reflects Eurofins accreditation under these programs, the report must not be used by the client to claim product certification, approval, or endorsement by A2LA or any agency of the Federal Government. This letter of transmittal is not a part of the attached report. Eurofins MET Laboratories Inc. (Eurofins E&E North America) is part of the Eurofins Electrical & Electronics (E&E) global compliance network. Seno Medical instruments Inc. Electromagnetic Compatibility Imagio 9100 (Model: 9100) CFR Title 47, Part 15.225 and RSS-210 Issue 10 Report: WIR120126-FCC15.225_RSS-210_R1 © 2022, Eurofins E&E North America Page 2 of 45 DOC-EMC702 6/18/2009 Electromagnetic Compatibility Criteria Test Report for the Seno Medical instruments Inc. Imagio 9100 Model: 9100 Tested under the FCC Certification Rules contained in 15.225 Subpart C and RSS-210: Issue 10 for Intentional Radiators Report: WIR120126-FCC15.225_RSS-210_R1 9/14/2022 Prepared For: Seno Medical Instruments Inc. Alfredo Ramirez 8023 Vantage Dr., Ste. 1000 San Antonio, TX 78230 Prepared By: Eurofins E&E North America 13501 McCallen Pass, Austin, TX 78753 Seno Medical instruments Inc. Electromagnetic Compatibility Imagio 9100 (Model: 9100) CFR Title 47, Part 15.225 and RSS-210 Issue 10 Report: WIR120126-FCC15.225_RSS-210_R1 © 2022, Eurofins E&E North America Page 3 of 45 DOC-EMC702 6/18/2009 Electromagnetic Compatibility Criteria Test Report for the Seno Medical instruments Inc. Imagio 9100 Model: 9100 Tested under the FCC Certification Rules contained in 15.225 Subpart C and RSS-210: Issue 10 for Intentional Radiators Report: WIR120126-FCC15.225_RSS-210_R1 9/14/2022 Sergio Gutierrez, EMC Test Engineer Bryan Taylor, Wireless Team Lead Engineering Statement: The measurements shown in this report were made in accordance with the procedures indicated, and the emissions from this equipment were found to be within the limits applicable. I assume full responsibility for the accuracy and completeness of these measurements, and for the qualifications of all persons taking them. It is further stated that upon the basis of the measurements made, the equipment tested is capable of operation in accordance with the requirements of the FCC Rules Part 15.225 and RSS-210 Issue 10 under normal use and maintenance. Seno Medical instruments Inc. Electromagnetic Compatibility Imagio 9100 (Model: 9100) CFR Title 47, Part 15.225 and RSS-210 Issue 10 Report: WIR120126-FCC15.225_RSS-210_R1 © 2022, Eurofins E&E North America Page 4 of 45 DOC-EMC702 6/18/2009 Report Status Sheet Revision Report Date Reason for Revision  7/22/2022 Initial Issue. R1 9/14/2022 Updated model number Seno Medical instruments Inc. Electromagnetic Compatibility Imagio 9100 (Model: 9100) CFR Title 47, Part 15.225 and RSS-210 Issue 10 Report: WIR120126-FCC15.225_RSS-210_R1 © 2022, Eurofins E&E North America Page 5 of 45 DOC-EMC702 6/18/2009 Table of Contents I. Executive Summary .................................................................................................................................................8 A. Purpose of Test ...................................................................................................................................................8 B. Executive Summary ............................................................................................................................................8 II. Equipment Configuration .......................................................................................................................................9 A. Overview .............................................................................................................................................................9 B. References ......................................................................................................................................................... 10 C. Test Site ............................................................................................................................................................ 11 D. Measurement Uncertainty ................................................................................................................................. 11 E. Description of Test Sample ............................................................................................................................... 12 F. Equipment Configuration .................................................................................................................................. 13 G. Support Equipment ........................................................................................................................................... 13 H. Ports and Cabling Information ..............................................................................................................…

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