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AV Cardiac CT

by Philips Medical Systems Nederland B.V.

510(k) K260169

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK260169 Date5 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AV Cardiac CT is a Class 2 Radiology device with product code JAK, substantially equivalent to a predicate device and cleared through the Traditional 510(k) pathway. It includes CT Coronary Analysis and CT Functional Analysis applications for the analysis of coronary artery anatomy and cardiac function in patients with suspected or diagnosed coronary artery disease, using gated cardiac CT data, including conventional and spectral acquisitions.

The device is manufactured by Philips Medical Systems Nederland B.V. and was cleared by the FDA under K260169 on March 5, 2026, following a 44-day review. It is supplied as a software application for use with cardiac CT imaging systems in clinical radiology settings, with no indication of sterility, single-use status, MRI safety, sizes, or storage conditions provided in the data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is AV Cardiac CT used for?

    AV Cardiac CT is used for the analysis of coronary artery anatomy and cardiac function in patients with suspected or diagnosed coronary artery disease, utilizing gated cardiac CT data from conventional and spectral acquisitions to support clinical assessment in radiology settings.

  • How is AV Cardiac CT supplied and deployed?

    AV Cardiac CT is supplied as a software application designed for use with cardiac CT imaging systems in clinical radiology environments, requiring integration with compatible imaging hardware and not involving any physical components, sterility, or single-use elements.

  • What regulatory pathway was used for AV Cardiac CT clearance?

    AV Cardiac CT received FDA clearance through the Traditional 510(k) pathway under submission K260169, demonstrating substantial equivalence to a predicate device with product code JAK in the Radiology device class.