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Chondral Quant VA10A

by Siemens Healthcare GmbH

Ref VA10AModel MDR_02_IIa_ERLN H 127_ACDV_SaMD

Chondral Quant VA10A is a device classified as Class IIa in the EU and Class II in the US made by Siemens Healthcare GmbH, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 0405686900128UW), cleared under FDA 510(k) K231351 on 13 Jul 2023 and listed in FDA GUDID since 17 Jul 2023 (UDI-DI 04056869964386), 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) K231351

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686900128UW Basic UDI-DI 04056869964386UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04056869964386 UDI-DI Date17 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK231351 Date13 Jul 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900128UW registered 10 Jul 2026 Active
  • FDA 510(k) K231351 decided 13 Jul 2023 Active
  • FDA GUDID UDI-DI 04056869964386 listed 17 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K231351
  2. Listed FDA GUDID 04056869964386
  3. Registered EUDAMED 0405686900128UW

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  • Withdrawn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
Chondral Quant
Generic name
MRI system application software
Device name
MDR_02_IIa_ERLN H 127_ACDV_SaMD
Model / reference
VA10A, MDR_02_IIa_ERLN H 127_ACDV_SaMD
Primary DI / UDI-DI
04056869964386
Basic UDI-DI
0405686900128UW
510(k) Number
FDA product code
LLZ
EMDN code
Z11050192 Magnetic resonance (MR) systems - medical device software
GMDN term
MRI system application software
Device class
Class IIa 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: MRI system application software

Similar devices in this category

Other devices filed under MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE.

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

  • Serial number
Other properties (24, all answered No)