cvi42 cardiovascular imaging software v6.X

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK251027	Date27 Oct 2025Decided	StatusActive
European Union	CE/MDD EUDAMED	Number882916C42WX Basic UDI-DI 00882916000028UDI-DI	Date7 Jan 2025Registered	StatusActive
European Union	CE/MDR EUDAMED	Number882916C42WX Basic UDI-DI 00882916000028UDI-DI	Date7 Jan 2025Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK242781	Date15 Oct 2024Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK241038	Date7 Jun 2024Decided	StatusActive
United States	GUDID listing GUDID	Number00882916000028 UDI-DI	Date15 Jan 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK232661	Date7 Dec 2023Decided	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK213998	Date28 Jul 2022Cleared	StatusActive
United States	FDA 510(k) 510(k)	NumberK141480	Date22 Aug 2014Issued	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK111373	Date23 Aug 2011Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK082628	Date20 Nov 2008Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 882916C42WX — open Devices and search for it
AccessGUDID record UDI-DI 00882916000028
FDA 510(k) database 510(k) number K251027
FDA 510(k) database 510(k) number K242781
FDA 510(k) database 510(k) number K241038
FDA 510(k) database 510(k) number K232661
FDA 510(k) database 510(k) number K213998
FDA 510(k) database 510(k) number K141480
FDA 510(k) database 510(k) number K111373
FDA 510(k) database 510(k) number K082628

Across registries

3 registries list this device

FDA 510(k) K251027 decided 27 Oct 2025 Active· +7 more in the status table
EUDAMED Basic UDI-DI 882916C42WX registered 7 Jan 2025 Active· +1 more in the status table
FDA GUDID UDI-DI 00882916000028 listed 15 Jan 2024 Listed

Timeline

10 dated events

20 Nov 2008 Cleared FDA 510(k) K082628
23 Aug 2011 Cleared FDA 510(k) K111373
22 Aug 2014 Cleared FDA 510(k) K141480
28 Jul 2022 Cleared FDA 510(k) K213998
7 Dec 2023 Cleared FDA 510(k) K232661
15 Jan 2024 Listed FDA GUDID 00882916000028
7 Jun 2024 Cleared FDA 510(k) K241038
15 Oct 2024 Cleared FDA 510(k) K242781
7 Jan 2025 Registered EUDAMED 882916C42WX
27 Oct 2025 Cleared FDA 510(k) K251027

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD, CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name: MRI system application software
Model / reference: v5.X EUDAMED
v6.X EUDAMED
6.x GUDID

Primary DI / UDI-DI: 00882916000028
Basic UDI-DI: 882916C42WX, B-00882916000028
Direct marketing DI: 00882916000028
510(k) Number: K213998
K082628
K111373
K141480
K232661
K241038
K242781
K251027
FDA product code: QIH, LLZ
EMDN code: Z11030582, V92
GMDN term: MRI system application software

Device class: Class IIa EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 892.2050
Special device type: Software
EU registration type: Standard device
Legacy device (under a directive)
EU market of registration: Germany
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

Field	EUDAMED	510(k)	GUDID
Model / reference	EUDAMED v5.X, v6.X v6.X	510(k) —	GUDID 6.x
Device class	EUDAMED Class IIa	510(k) Class II	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 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

CT42 Cardiac Computed Tomography (Ct) Software K111373 23 Aug 2011 FDA record · FDA summary
CMR42 Cardiac Mri Imaging System, 2.1.23 K082628 20 Nov 2008 FDA record

Cited by

cvi42 Coronary Plaque Software Application K251027 27 Oct 2025 FDA record · FDA summary
Salix Central K243038 27 Mar 2025 FDA record · FDA summary
Myomics K241922 28 Feb 2025 FDA record · FDA summary
1CMR Pro K242062 15 Nov 2024 FDA record · FDA summary
TeraRecon Cardiac.Chambers.MR (1.0.0) K241312 5 Nov 2024 FDA record · FDA summary
cvi42 Software Application K242781 15 Oct 2024 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN: CA-MF-000011835
Authorised representative: QDossier B.V. NL-AR-000033747

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

cvi42 is a cardiovascular imaging software device used for cardiac MRI analysis. It provides tools for diagnosis, quantification, and qualification for research purposes, supporting image post-processing across different scanning platforms.

The device is supplied as non-sterile, non-implantable, and non-reusable software (REUSABLE: 0, IMPLANTABLE: 0, STERILE: 0). It is an active device with measuring function (ACTIVE: 1, MEASURING_FUNCTION: 1) and is authorised under FDA 510(k), MDD, and MDR regulations. It is used in clinical and research settings for cardiac imaging workflows, including AI-enabled quantification of atherosclerotic burden.

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Properties

Measuring function
Prescription use
Serial number

Other properties (22, all answered No)