Approval for the imagio breast imaging system. The device is indicated for use by a trained and qualified healthcare provider for evaluation of palpable 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 the diagnosis 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 the bi-rads classifications. This device is not intended to be used as a replacement for mammographic screening or for definitive pathologic diagnosis.
| Device | Imagio Breast Imaging System |
| Generic Name | Optoacoustic Imaging System |
| Applicant | Seno Medical Instruments, Inc. |
| Date Received | 2020-01-31 |
| Decision Date | 2021-01-11 |
| PMA | P200003 |
| Supplement | S |
| Product Code | QNK |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Seno Medical Instruments, Inc. 8023 Vantage Drive, Suite 1000 san Antonio, TX 78230 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200003 | | Original Filing |
| S001 |
2021-11-01 |
Normal 180 Day Track |
NIH GUDID Devices