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QIR Suite

by Casis Cardiac Simulation & Imaging Software

510(k) K211611

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211611↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211611 Date30 Sep 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 · 510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The QIR Suite is a cardiac imaging software system designed for quantitative image reconstruction and analysis of cardiac magnetic resonance (CMR) data. It provides tools for assessing cardiac structure and function, enabling precise measurements of myocardial volume, mass, and ejection fraction to support diagnostic and clinical decision-making.

This software is supplied as a standalone application for use in radiology and cardiac imaging departments, requiring installation on a compatible computing platform. It is intended for single-use sessions per imaging study, with no indication of sterility or reusable components. The QIR Suite holds FDA 510(k) clearance under the Radiology advisory committee and is compliant with the EU Medical Device Regulation (MDR), with a product code of QIH.

Other devices from Casis Cardiac Simulation & Imaging Software

Questions

AI-generated answers, 18 Sep 2026

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

  • What clinical applications does the QIR Suite support in cardiac imaging?

    The QIR Suite is designed for quantitative analysis of cardiac magnetic resonance (CMR) data, enabling precise assessments of cardiac structure and function. Clinicians can use it to measure myocardial volume, mass, and ejection fraction—key metrics for diagnosing and evaluating heart conditions, such as cardiomyopathies or ischemic heart disease. It’s particularly useful in radiology and cardiac imaging departments for diagnostic decision-making.

  • How is the QIR Suite supplied, and what system requirements are implied for use?

    The QIR Suite is supplied as a standalone software application that must be installed on a compatible computing platform. Since it’s intended for single-use sessions per imaging study, it doesn’t include physical components like reusable or sterile hardware. Users will need a system capable of running the software, though exact hardware specifications (e.g., processor, RAM) aren’t detailed in the data.

  • Is the QIR Suite approved for use in both the U.S. and European markets, and how?

    Yes, the QIR Suite holds FDA 510(k) clearance under the Radiology advisory committee (K211611) and is compliant with the EU Medical Device Regulation (MDR). The U.S. clearance was granted as substantially equivalent to a predicate device, while the MDR compliance ensures it meets EU safety and performance standards for medical software.

  • Does the QIR Suite include any reusable or sterile components, or is it intended for single-use?

    The QIR Suite is explicitly described as a software-only solution for single-use sessions per imaging study. Since it lacks physical components like reusable probes or sterile hardware, there are no sterility considerations or reuse requirements—only the software installation on a dedicated system.