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cvi42 5.x

by Circle Cardiovascular Imaging

Ref v5.x

cvi42 5.x is a device classified as Class IIa in the EU and Class II in the US made by Circle Cardiovascular Imaging, registered in EUDAMED on 4 Aug 2022 (Basic UDI-DI B-00882916000011), cleared under FDA 510(k) K141480 on 22 Aug 2014 (2 earlier submissions) and listed in FDA GUDID since 6 May 2019 (UDI-DI 00882916000011), active as of 23 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141480

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00882916000011 Basic UDI-DI 00882916000011UDI-DIDate4 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00882916000011 UDI-DI Date6 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK141480 Date22 Aug 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00882916000011 registered 4 Aug 2022 Active
  • FDA 510(k) K141480 decided 22 Aug 2014 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00882916000011 listed 6 May 2019 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K082628
  2. Cleared FDA 510(k) K111373
  3. Cleared FDA 510(k) K141480
  4. Listed FDA GUDID 00882916000011
  5. Registered EUDAMED B-00882916000011

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
cvi42
Generic name
MRI system application software
Model / reference
v5.x EUDAMED
5.x GUDID
Primary DI / UDI-DI
00882916000011
Basic UDI-DI
B-00882916000011
510(k) Number
FDA product code
LLZ
EMDN code
V92 Medical device software - not included in other classes
GMDN term
MRI system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
v5.x
GUDID
5.x
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 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Circle Cardiovascular Imaging

See all devices from Circle Cardiovascular Imaging →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (20, all answered No)