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FDA 510(k)

Rapid Aortic Measurements

K-Number: K251987 · 2025-09-23

ApplicantIschemaview, Inc.
Decision Date2025-09-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid Aortic Measurements is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-09-23 under approval number K251987. 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 Rapid Aortic Measurements?

Rapid Aortic Measurements is a medical device that received FDA 510(k) clearance on 2025-09-23. It is manufactured by Ischemaview, Inc.. The 510(k) number is K251987.

When was Rapid Aortic Measurements approved by the FDA?

Rapid Aortic Measurements received FDA 510(k) clearance on 2025-09-23, under approval number K251987.

What company makes Rapid Aortic Measurements?

Rapid Aortic Measurements is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid Aortic Measurements?

The FDA product code for Rapid Aortic Measurements is 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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