FDA.reportPublic FDA data

PMA P200003

Device
Imagio® Breast Imaging system
Applicant
Seno Medical Instruments, Inc.
PMA number
P200003
Supplement
S001
Product code
QNK
Decision date
2022-06-17
Generic name
Optoacoustic Imaging System
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.

Current openFDA PMA Record#

Device
Imagio® Breast Imaging system
Applicant
Seno Medical Instruments, Inc.
PMA number
P200003
Supplement
S001
Product code
QNK
Generic name
Optoacoustic Imaging System
Decision date
2022-06-17
Decision code
APPR
Date received
2021-11-01
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.