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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2026-03-05 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K260169.

When did AV Cardiac CT receive FDA 510(k) clearance?

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

Who is the listed applicant for AV Cardiac CT?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

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.

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