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Imagio Breast Imaging System

by Seno Medical Instruments, Inc.

PMA P200003

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P200003↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200003 Date11 Jan 2021ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Optoacoustic Imaging System
PMA Number
FDA Product Code
QNK
Device Class
Class III
Advisory Committee
Radiology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Imagio Breast Imaging System is an optoacoustic imaging system used for the evaluation of palpable and non-palpable breast abnormalities in adult patients. It is indicated for use by trained and qualified healthcare providers for diagnostic imaging breast work-up, following clinical presentation or screening or diagnostic mammography or other imaging examinations. The system includes an ultrasound mode and an opto-acoustic (OA) mode, which provides information about the central nidus, boundary, and peripheral zones based on vascularity and blood oxygen saturation of the imaged tissues. The system also includes an artificial intelligence (AI) based software function to assist users in assessing BI-RADS classifications.

The Imagio Breast Imaging System is supplied with FDA PMA authorization and is intended for use in a clinical setting. It is not intended to be used as a replacement for mammographic screening or for definitive pathologic diagnosis. The system is designed to assist in the diagnosis of benign or malignant masses, and the OA mode is not indicated for ultrasound BI-RADS 1 and 2 findings.

From the manufacturer

Imagio® delivers real-time, functional diagnostic imaging to support the assessment of whether a mass is benign or malignant with a single exam.

Source: senomedical.com

Imagio®, an innovative new modality for improving the cancer diagnostic imaging process through the fusion of opto-acoustics with gray-scale ultrasound.

Source: senomedical.com

Other devices from Seno Medical Instruments, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Imagio Breast Imaging System used for?

    The Imagio Breast Imaging System is used for the evaluation of palpable and non-palpable breast abnormalities in adult patients, following clinical presentation or screening or diagnostic mammography or other imaging examinations.

  • What modes does the Imagio Breast Imaging System have?

    The Imagio Breast Imaging System has two modes: an ultrasound mode and an opto-acoustic (OA) mode, which provides information about the central nidus, boundary, and peripheral zones based on vascularity and blood oxygen saturation of the imaged tissues.

  • Is the Imagio Breast Imaging System intended to replace mammographic screening?

    No, the Imagio Breast Imaging System is not intended to be used as a replacement for mammographic screening or for definitive pathologic diagnosis.