Devices · Seno Medical Instruments, Inc.

Imagio Breast Imaging System

Seno Medical Instruments, Inc. is listed for Imagio Breast Imaging System (P200003). The FDA list gives January 11, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the PMA pathway. openFDA describes product code QNK as “Optoacoustic Imaging System”: The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis openFDA records decision code APPR for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200003

Official FDA database record

Date of final decision

January 11, 2021

Company on the FDA list

Seno Medical Instruments, Inc.

Lead panel

Radiology

Primary product code

QNK

openFDA device name for the code

Optoacoustic Imaging System

Device class

3

Regulation number

Not returned

openFDA decision description

Not returned

openFDA decision code

APPR

Statement or summary label

Statement