510(k) Report

FDA applicant

Philips Healthcare (Suzhou) Co., Lit.

Suzhou, CN1 decision2020–20203 recalls

FDA records 1 decision for Philips Healthcare (Suzhou) Co., Lit. (Suzhou, CN) in 2020: 1 510(k) clearance. All are in product code KPR (System, X-Ray, Stationary). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 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 (Suzhou) Co., Lit.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2023

2022: 12023: 2
2020high 2 (2023) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Philips Healthcare (Suzhou) Co., Lit. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips Healthcare (Suzhou) Co., Lit.’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?

  • KPRSystem, X-Ray, Stationary1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 20203 recalls

The one decision as Philips Healthcare (Suzhou) Co., Lit. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K201725DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human…Mar 9, 2023Class II
  • K201725Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human…Mar 9, 2023Class II
  • K163410DigitalDiagnost C50 1.1Feb 25, 2022Class II