This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Imagio® Breast Imaging System
PMA Applicant: Seno Medical Instruments, Inc.
Address: 8023 Vantage Drive, Suite 1000,
San Antonio, TX 78230
Approval Date: January 11, 2021
Approval Letter: Approval Order
What is it?
How does it work?
The Imagio® Breast Imaging System has software and hardware that produces OA images and conventional ultrasound images of the breast. First, ultrasound mode is used initially to assess any focal area(s) of clinical or imaging concerns. For ultrasound BI-RADS 3-5 masses, using the OA images allows for improved classification compared to ultrasound alone. The OA mode is not indicated for ultrasound BI- RADS 1 and 2 findings. The Imagio® Breast Imaging System includes an Artificial Intelligence (AI) based software function to assist the users with BI-RADS classifications.
When is it used?
The Imagio Breast Imaging System is used when a physician finds an unusual area of breast tissue using mammography and ultrasound. The OA images generated using this device are used to evaluate breast lesions.
What will it accomplish?
The OA images generated using Imagio Breast Imaging System could provide more information on the region of breast being imaged such as the structure and function (e.g., blood oxygen level) comparing to ultrasound images alone. This additional information for ultrasound BI-RADS 3-5 masses could help physicians in evaluating breast lesions and assessing BI-RADS classifications.
When should it not be used?
The Imagio Breast Imaging System should not be used in people who:
- Are pregnant
- Have open sores like insect bites, rash, poison ivy, or scratches on the skin on the side of the breast)
- Are experiencing effects like phototoxicity (irritation due to light) because of taking drugs such as sulfonamides, ampicillin, tetracycline within the last 72 hours
- Are going through phototherapy
- Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus)
- Are being treated for a photosensitive disease or are experiencing photosensitivity