FDA 510(k)

AV Cardiac CT

K-Number: K260169 · 2026-03-05

ApplicantPhilips Medical Systems Nederland B.V.

Decision Date2026-03-05

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AV Cardiac CT is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2026-03-05 under approval number K260169. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AV Cardiac CT?

AV Cardiac CT is a medical device that received FDA 510(k) clearance on 2026-03-05. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K260169.

When was AV Cardiac CT approved by the FDA?

AV Cardiac CT received FDA 510(k) clearance on 2026-03-05, under approval number K260169.

What company makes AV Cardiac CT?

AV Cardiac CT is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for AV Cardiac CT?

The FDA product code for AV Cardiac CT is JAK.

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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.