FDA 510(k)

QIR Suite

K-Number: K211611 · 2022-09-30

ApplicantCasis Cardiac Simulation & Imaging Software

Decision Date2022-09-30

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QIR Suite is the device name listed in this FDA 510(k) record. The listed applicant is Casis Cardiac Simulation & Imaging Software. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K211611. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIR Suite?

QIR Suite is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Casis Cardiac Simulation & Imaging Software. The 510(k) number is K211611.

When did QIR Suite receive FDA 510(k) clearance?

QIR Suite received FDA 510(k) clearance on 2022-09-30, under 510(k) number K211611.

Who is the listed applicant for QIR Suite?

The FDA 510(k) record lists Casis Cardiac Simulation & Imaging Software as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QIR Suite?

The FDA product code for QIR Suite is QIH.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.