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syngo.Breast Care 11343179

by Siemens Healthcare EUDAMEDGUDID

Active European Union

Ref 11343179Model MDR_18_II b_ERLN H 127_WHSAMD

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04056869225333 UDI-DIDate16 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0405686901980WF Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2107-2016 FDA Class II initiated 6 Jun 2016

    Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read. 2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).

Specification

EUDAMED · GUDID

Trade Name
syngo.Breast Care
Generic Name
Diagnostic x-ray digital imaging system workstation application software
Device Name
MDR_18_II b_ERLN H 127_WHSAMD
Model / Ref / Catalog
11343179, MDR_18_II b_ERLN H 127_WHSAMD
Primary DI / UDI-DI
04056869225333
Basic UDI-DI
0405686901980WF
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11030292 Mammography systems - medical device software
GMDN Term
Diagnostic x-ray digital imaging system workstation application software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K123420)

Other devices from Siemens Healthcare

See all devices from Siemens Healthcare →

Properties

  • Prescription Use

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No