cvi42

EUDAMEDFDA 510(k)FDA UDI

Class IIa (EU MDR)

Ref v6.XModel v5.X, v6.X510(k) K141480510(k) K213998

by Circle Cardiovascular Imaging Inc

Identity

Trade Name: cvi42 EUDAMEDFDA UDI
Generic Name: MRI system application software FDA UDI
Device Name: cvi42 EUDAMED
Model / Reference: v5.X, v6.X EUDAMED
v6.X EUDAMED
6.x FDA UDI

Identifiers

Primary DI / UDI-DI: 00882916000028 EUDAMEDFDA UDI
Basic UDI-DI: 882916C42WX EUDAMED
B-00882916000028 EUDAMED
Direct Marketing DI: 00882916000028 EUDAMED
510(k) Number: K213998 FDA 510(k)FDA UDI
K082628 FDA UDI
K111373 FDA UDI
K141480 FDA UDI
K232661 FDA UDI
K242781 FDA UDI
FDA Product Code: QIH FDA 510(k)FDA UDI
LLZ FDA UDI
EMDN Code: Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
GMDN Term: MRI system application software FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 892.2050 FDA 510(k)
Regulation Number: 892.2050 FDA 510(k)FDA UDI
Special Device Type: Software EUDAMED
-1192 EUDAMED
Market of Registration: Germany EUDAMED
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

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.

Frequently asked questions

What is cvi42 used for?

cvi42 is a cardiovascular imaging software device used for cardiac MRI analysis, providing tools for diagnosis, quantification, and qualification for research purposes, supporting image post-processing across different scanning platforms, including AI-enabled quantification of atherosclerotic burden.

How is cvi42 supplied and is it reusable or sterile?

cvi42 is supplied as non-sterile, non-implantable, and non-reusable software, meaning it is not designed for reuse, does not require sterilization, and is not intended for implantation, as indicated by REUSABLE: 0, IMPLANTABLE: 0, and STERILE: 0 in the device data.

What versions or models of cvi42 are available?

cvi42 is available in device models v5.X and v6.X, with the reference version specified as v6.X, indicating these are the distinct model references that differentiate this device from others in the manufacturer's lineup.

Does cvi42 have a measuring function and is it an active device?

Yes, cvi42 is an active device with a measuring function, as confirmed by ACTIVE: 1 and MEASURING_FUNCTION: 1 in the specifications, meaning it requires a power source to operate and performs quantitative measurements on cardiac MRI data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cardiac Imaging Software | Circle Cardiovascular Imaging (Circle CVI), Cardiovascular Imaging Software | Circle CVI | Global, cvi42 Cardiovascular MRI | Circle Cardiovascular Imaging Inc., cvi42 | Plaque

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	882916C42WX	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K213998	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K141480	Class IIa	Active
EUDAMED	European Union	CE/MDR	882916C42WX	Class IIa	Active

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Manufacturer

Manufacturer: Circle Cardiovascular Imaging Inc
EUDAMED SRN: CA-MF-000011835
FDA Applicant: Circle Cardiovascular Imaging, Inc.
Authorised Representative: QDossier B.V. NL-AR-000033747

Sources (4)

EUDAMED 9ef67448-e3b0-4eee-9f1e-91bd018cdeb9 85 fields · synced Sep 21, 2026
FDA 510(k) K213998 24 fields · synced May 18, 2026
FDA UDI 29304589-d56a-4b9e-8bce-5e7f511743c2 33 fields · synced May 30, 2026
EUDAMED 81a024ef-22d7-4fae-b354-c16347cae162 61 fields · synced Aug 3, 2026