510(k) Report

FDA applicant

Philips Medical Systems Technologies, Ltd.

Haifa, IL5 decisions2018–20263 recalls

FDA records 5 decisions for Philips Medical Systems Technologies, Ltd. (Haifa, IL) from 2018 to 2026: 5 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Philips Medical Systems Technologies”.

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 Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12024: 22025: 12026 (partial year): 1
2018high 2 (2024) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

3in 2026

2026 (partial year): 3
2018high 3 (2026) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Philips Medical Systems Technologies, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Medical Systems Technologies…’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?

  • JAKSystem, X-Ray, Tomography, Computed3decisions
  • LLZSystem, Image Processing, Radiological2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 127 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 20243cite it
  • K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 20181cites it

What has FDA decided for it lately?

  • K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd. · 2026
  • K244008Spectral CTPhilips Medical Systems Technologies, Ltd. · 20253 recalls
  • K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
  • K240822Image Management V15Philips Medical Systems Technologies · 2024
  • K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018

All 4 as Philips Medical Systems Technologies, Ltd. →The one decision as Philips Medical Systems Technologies →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K244008Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X…Aug 21, 2026Class II
  • K244008Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product…Aug 18, 2026Class II
  • K244008Spectral CT; Product Code (REF): 728333;Jan 7, 2026Class II