# cvi42

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/cvi42-v6-x>
- Manufacturer: [Circle Cardiovascular Imaging Inc](https://devicerts.com/manufacturers/circle-cardiovascular-imaging) (Canada)
- Device class: Class IIa (EU MDD / EU MDR); Class II (US FDA)
- FDA product code: QIH, LLZ
- EMDN: Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
- EMDN: V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES
- GMDN: MRI system application software (40872)

## Overview

*AI-generated summary, 2026-09-21. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data 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.

## Registrations and authorizations

- **GUDID** · FDA 510(k) · United States · K251027 · decision 2025-10-27 · decision SESE · status: Active · from GUDID
- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI 882916C42WX · UDI-DI 00882916000028 · registered 2025-01-07 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 882916C42WX · UDI-DI 00882916000028 · registered 2025-01-07 · status: Active
- **GUDID** · FDA 510(k) · United States · K242781 · decision 2024-10-15 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K241038 · decision 2024-06-07 · decision SESE · status: Active · from GUDID
- **GUDID** · GUDID listing · United States · UDI-DI 00882916000028 · listed 2024-01-15 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K232661 · decision 2023-12-07 · decision SESE · status: Active · from GUDID
- **510(k)** · FDA 510(k) · United States · K213998 · decision 2022-07-28 · decision SESE · status: Active
- **510(k)** · FDA 510(k) · United States · K141480 · issued 2014-08-22 · status: Active
- **GUDID** · FDA 510(k) · United States · K111373 · decision 2011-08-23 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K082628 · decision 2008-11-20 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Generic name: MRI system application software [FDA GUDID (AccessGUDID)]
- Model / reference: v5.X [EUDAMED]; v6.X [EUDAMED]; 6.x [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00882916000028 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 882916C42WX [EUDAMED]; B-00882916000028 [EUDAMED]
- Direct marketing DI: 00882916000028 [EUDAMED]
- 510(k) Number: K213998 [FDA 510(k), FDA GUDID (AccessGUDID)]; K082628 [FDA GUDID (AccessGUDID)]; K111373 [FDA GUDID (AccessGUDID)]; K141480 [FDA GUDID (AccessGUDID)]; K232661 [FDA GUDID (AccessGUDID)]; K241038 [FDA GUDID (AccessGUDID)]; K242781 [FDA GUDID (AccessGUDID)]; K251027 [FDA GUDID (AccessGUDID)]
- FDA product code: QIH [FDA 510(k), FDA GUDID (AccessGUDID)]; LLZ [FDA GUDID (AccessGUDID)]
- EMDN code: Z11030582 [EUDAMED]; V92 [EUDAMED]
- GMDN term: MRI system application software (40872) [FDA GUDID (AccessGUDID)]

## Classification

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

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: cvi42, Circle Cardiovascular Imaging Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/cvi42-v6-x (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/cvi42-v6-x.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/cvi42-v6-x
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.