510(k) Report

FDA applicant

Philips Medical Systems (Cleveland), Inc.

Cleveland, OH190 decisions1977–2017279 recalls

FDA records 190 decisions for Philips Medical Systems (Cleveland), Inc. (Cleveland, OH) from 1977 to 2017: 190 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 107 predicates, 54 of them its own earlier devices. 279 recalls are linked to its devices, 2 Class I.

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 Medical Systems (Cleveland), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2017

2008: 42009: 42011: 22013: 12016: 22017: 5
2007high 5 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2026

2007: 82008: 112009: 62010: 22011: 242012: 232013: 152014: 112015: 392016: 332017: 312018: 142019: 112020: 22021: 162022: 12023: 7, 2 Class I2025: 82026 (partial year): 2
2007high 39 (2015) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Philips Medical Systems (Cleveland), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Medical Systems (Cleveland)…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging57decisions
  • JAKSystem, X-Ray, Tomography, Computed24decisions
  • KPSSystem, Tomography, Computed, Emission20decisions
  • KPRSystem, X-Ray, Stationary8decisions
  • HAWNeurological Stereotaxic Instrument7decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified6decisions

Also: MOS (6), LLZ (5), IZO (5), IXY (4), IYO (4), IZL (4).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 133 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 96 days; 1 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 107 predicates; 54 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 147 times; 54 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.

  • K945827OutlookPhilips Medical Systems (Cleveland), Inc. · 19958cite it
  • K060937Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 20068cite it
  • K923851Acqsim Simulator/LocalizerPhilips Medical Systems (Cleveland), Inc. · 19927cite it
  • K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 20056cite it
  • K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 19976cite it
  • K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 20046cite it

What has FDA decided for it lately?

  • K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 201714 recalls
  • K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc. · 20173 recalls
  • K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc. · 20176 recalls
  • K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 20172 recalls
  • K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 20173 recalls
  • K160743Philips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. · 201624 recalls
  • K153444Philips Multislice CT System with Low Dose CT Lung CancerPhilips Medical Systems (Cleveland), Inc. · 2016
  • K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 20131 recall

All 190 as Philips Medical Systems (Cleveland), Inc. →

What has been recalled?

279 recalls linked to its devices; the latest:

  • K160743Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China…Aug 7, 2026Class II
  • K160743Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium…Jun 11, 2026Class II
  • K060937Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.Aug 13, 2025Class II
  • K160743Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number…Aug 13, 2025Class II
  • K171850Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2.…Aug 13, 2025Class II
  • K162838Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.Aug 13, 2025Class II