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Siemens Mammomat NovationDR Full Field Digital Mammography System

by Siemens Medical Solution

PMA P030010

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P030010↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP030010 Date20 Aug 2004DecidedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1233-2009 FDA Unclassified (pre-2012) initiated 23 Jan 2009

    Image may appear dark, requiring repeat image acquisition.

    • Terminated Z-1045-05 FDA Unclassified (pre-2012) initiated 25 May 2005 on shared PMA P030010

    potential issue (image acquisition may become interrupted) when using multiple network nodes

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Full field digital, system, x-ray, mammographic
PMA Number
FDA Product Code
MUE
Device Class
Class II
Regulation
21 CFR Part 892.1715
Advisory Committee
Radiology
FDA Decision
APRL

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 Siemens Mammomat NovationDR Full Field Digital Mammography System is a full-field digital x-ray mammographic imaging device designed to generate digital mammographic images. It is classified as a full-field digital mammographic system and is intended for screening and diagnostic evaluation of breast cancer, replacing traditional film-based mammographic systems.

This system is used in radiology settings to produce digital images that can be interpreted via hardcopy film or softcopy at a workstation. It is a Class II device under FDA regulations, with an FDA PMA approval (P030010) and registration numbers listed under regulation 892.1715. The device is non-sterile, reusable, and intended for use in clinical environments where breast imaging is performed.

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