Imagio® Breast Imaging system

FDA Premarket Approval P200003 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceImagio® Breast Imaging system
Generic NameOptoacoustic Imaging System
ApplicantSeno Medical Instruments, Inc.8023 Vantage Drive, Suite 1000san Antonio, TX 78230 PMA NumberP200003 Supplement NumberS001 Date Received11/01/2021 Decision Date06/17/2022 Product Code QNK  Advisory Committee Radiology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2021-11-01
Decision Date2022-06-17
PMAP200003
SupplementS001
Product CodeQNK 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressSeno Medical Instruments, Inc.
8023 Vantage Drive, Suite 1000
san Antonio, TX 78230 PMA NumberP200003 Supplement NumberS001 Date Received11/01/2021 Decision Date06/17/2022 Product Code QNK  Advisory Committee Radiology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material 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.

Supplemental Filings

Supplement NumberDateSupplement Type
P200003Original Filing
S001 2021-11-01 Normal 180 Day Track

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