510(k) Report

FDA applicant

Philips Healthcare (Cleveland)

Cleveland, OH6 decisions2011–201415 recalls

FDA records 6 decisions for Philips Healthcare (Cleveland) (Cleveland, OH) from 2011 to 2014: 6 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and KPS (System, Tomography, Computed, Emission). Its devices cite 8 predicates, 2 of them its own earlier devices. 15 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Philips Healthcare (Cleveland)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12012: 12013: 32014: 1
2011high 3 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2021

2012: 12015: 32016: 32017: 12018: 42019: 22021: 1
2011high 4 (2018) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Philips Healthcare (Cleveland) by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed4decisions
  • KPSSystem, Tomography, Computed, Emission1decision
  • OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 20142cite it
  • K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 20132cite it
  • K131773Brilliance IctPhilips Healthcare (Cleveland) · 20131cites it
  • K113483Iterative Reconstruction Technique Software ApplicationPhilips Healthcare (Cleveland) · 20121cites it

What has FDA decided for it lately?

  • K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 20146 recalls
  • K131773Brilliance IctPhilips Healthcare (Cleveland) · 2013
  • K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 20135 recalls
  • K123576Imr Software ApplicationPhilips Healthcare (Cleveland) · 2013
  • K113483Iterative Reconstruction Technique Software ApplicationPhilips Healthcare (Cleveland) · 2012
  • K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland) · 20114 recalls

All 6 as Philips Healthcare (Cleveland) →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K123599Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos…May 1, 2021Class II
  • K123599Vereos PET/CT Model # 882446, computed tomography x-ray systemJun 24, 2019Class II
  • K123599Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and…Jun 3, 2019Class II
  • K123599Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips…Sep 4, 2018Class II
  • K123599Ingenuity Digital PET/CT System, Model 882446 with the following UDI's…May 21, 2018Class II
  • K133674IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage…Feb 8, 2018Class II