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FDA 510(k)

Rapid CTA 360

K-Number: K251151 · 2025-07-16

ApplicantIschemaview
Decision Date2025-07-16
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid CTA 360 is a medical device manufactured by Ischemaview. It received FDA 510(k) clearance on 2025-07-16 under approval number K251151. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid CTA 360?

Rapid CTA 360 is a medical device that received FDA 510(k) clearance on 2025-07-16. It is manufactured by Ischemaview. The 510(k) number is K251151.

When was Rapid CTA 360 approved by the FDA?

Rapid CTA 360 received FDA 510(k) clearance on 2025-07-16, under approval number K251151.

What company makes Rapid CTA 360?

Rapid CTA 360 is manufactured by Ischemaview.

What is the FDA product code for Rapid CTA 360?

The FDA product code for Rapid CTA 360 is QAS.

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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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