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syngo Application Software 11327667

by Siemens Healthcare GmbH

Ref 11327667Model MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx)

syngo Application Software 11327667 is a basic x-ray clinical assessment support software (EU MDR Class IIb; FDA Class II; FDA product code LLZ, System, image processing, radiological) made by Siemens Healthcare GmbH, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 0405686900143US), cleared under FDA 510(k) K220433 on 16 Aug 2022 (1 earlier submission) and listed in FDA GUDID since 10 Jan 2020 (UDI-DI 04056869124162), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220433

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900143US Basic UDI-DI 04056869124162UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220433 Date16 Aug 2022DecidedStatusActive
United StatesGUDID listing GUDID Number04056869124162 UDI-DI Date10 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900143US registered 22 Jun 2026 Active
  • FDA 510(k) K220433 decided 16 Aug 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04056869124162 listed 10 Jan 2020 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K190780
  2. Listed FDA GUDID 04056869124162
  3. Cleared FDA 510(k) K220433
  4. Registered EUDAMED 0405686900143US

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
syngo Application Software
Generic name
Basic x-ray clinical assessment support software
Device name
MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx)
Model / reference
11327667, MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx)
Primary DI / UDI-DI
04056869124162
Basic UDI-DI
0405686900143US
510(k) Number
FDA product code
LLZ
EMDN code
Z11030192 Digital angiography systems - medical device software
GMDN term
Basic x-ray clinical assessment support software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU 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

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Basic diagnostic x-ray system application software

Cleared under the same submission (K190780)

Similar devices in this category

Other devices filed under DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE.

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)