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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceImagio Breast Imaging System
Generic NameOptoacoustic Imaging System
ApplicantSeno Medical Instruments, Inc.
8023 Vantage Drive, Suite 1000
San Antonio, TX 78230
PMA NumberP200003
Date Received01/31/2020
Decision Date01/11/2021
Product Code QNK 
Docket Number 21M-0070
Notice Date 01/13/2021
Advisory Committee Radiology
Clinical TrialsNCT01943916
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Imagio® Breast Imaging System. This device is indicated for use by a trained and qualified healthcare provider for evaluation ofpalpable and non-palpable breast abnormalities in adult patients who are referred for a diagnostic imaging breast work-up, following clinical presentation or either screening or diagnostic mammography or other imaging examinations. The ultrasound mode should be initially used in a targeted fashion, to assess any focal area(s) of clinical or imaging concerns. In ultrasound mode, the device can be used to assign a BI-RADS category to either breast tissue or a mass that is causing clinical or imaging concerns. Masses that are classified as BI-RADS categories 3 through 5 can then be assessed using the Opto-Acoustic (OA) mode. In the OA mode, the Imagio® Breast Imaging System provides information about the central nidus, boundary and peripheral zones, based on vascularity and blood oxygen saturation of the imaged tissues, to assist in thediagnosis of the benign or malignant mass(es) of interest. For ultrasound BI-RADS 3-5 masses, using the OA features of the mass allows for improved classification of the mass of interest as 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 in assessing BI-RADS classifications. This device is not intended to be used as a replacement formammographic screening or for definitive pathologic diagnosis.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001