Radiology · PMA · 2021
Imagio Breast Imaging System
Seno Medical Instruments, Inc.. Approved by FDA on 11 January 2021 under submission P200003, product code QNK (optoacoustic imaging system). What FDA's record says, in FDA's words.
Device record · P200003
- Device. Imagio Breast Imaging SystemDEVICE
- Company. Seno Medical Instruments, Inc.COMPANY
- Decision. 11 January 2021, PMA, apprDECISION
- Panel. RadiologyPANEL
- Product code. QNK, Optoacoustic Imaging SystemCODE
- Source. FDA database entry · decision document (33 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement, verbatim, from the decision document.
The Imagio Breast Imaging System 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 […]
The product code's definition, from FDA's classification record. The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code QNK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
11 August 2025 · Malfunction · IMAGIO BREAST IMAGING SYSTEM, MODEL 9100 · SENO MEDICAL, INC. · report 3014755924-2025-04001
DURING A PATIENT SCAN AND AFTER SAVING THE FIRST CLIP, THE SYSTEM BECAME COMPLETELY UNRESPONSIVE, I.E. NONE OF THE TOUCH TABS OR BUTTONS WERE FUNCTIONAL. AS A RESULT, SITE UNABLE TO PROCEED WITH THE SCAN AND HAD TO SHUT DOWN THE SYSTEM IN ORDER TO PREPARE IT FOR THE NEXT PATIENT. THIS WAS UNDERSTANDABLY DISTRESSING FOR THE PATIENT UNDERGOING BIOPSY AND QUITE CHALLENGING FOR OUR TEAM.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QNK, in Radiology, or approved in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.