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FDA 510(k)

cvi42 Software Application

K-Number: K242781 · 2024-10-15

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2024-10-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

cvi42 Software Application is the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K242781. 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 cvi42 Software Application?

cvi42 Software Application is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Circle Cardiovascular Imaging, Inc.. The 510(k) number is K242781.

When did cvi42 Software Application receive FDA 510(k) clearance?

cvi42 Software Application received FDA 510(k) clearance on 2024-10-15, under 510(k) number K242781.

Who is the listed applicant for cvi42 Software Application?

The FDA 510(k) record lists Circle Cardiovascular Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cvi42 Software Application?

The FDA product code for cvi42 Software Application is QIH.

Other records listing Circle Cardiovascular Imaging, Inc. as applicant

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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Related Devices (Code: QIH)

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Official Source

View on FDA Database →

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

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