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Ingenuity Digital PET/CT

by Philips Healthcare (Cleveland)

510(k) K123599

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK123599 Date12 Jul 2013ClearedStatusActive

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-1988-2021 FDA Class II initiated 1 May 2021

    Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

    • Terminated Z-2194-2019 FDA Class II initiated 24 Jun 2019 on shared 510(k) K123599

    In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

    • Terminated Z-1929-2019 FDA Class II initiated 3 Jun 2019

    The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.

    • Terminated Z-0302-2019 FDA Class II initiated 4 Sep 2018

    Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.

    • Terminated Z-2496-2018 FDA Class II initiated 21 May 2018

    The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Ingenuity Digital PET/CT is a diagnostic imaging system that combines Positron Emission Tomography and X-ray Computed Tomography. The CT subsystem captures anatomical cross-sections through the computer reconstruction of X-ray transmission data.

This device is classified as a Class 2 system under regulation number 892.1200. It has received FDA 510(k) clearance under the submission number K123599.

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