510(k) Report

FDA applicant

Philips Healthcare Informatics, Inc.

Foster City, CA2 decisions2011–20182 recalls

FDA records 2 decisions for Philips Healthcare Informatics, Inc. (Foster City, CA) from 2011 to 2018: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 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 Informatics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12018: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2019

2014: 12019: 1
2011high 1 (2014) · low 0 (2011)2026

Class I Class II/III not classified

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

Planning a device like Philips Healthcare Informatics, Inc.’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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 20112cite it

What has FDA decided for it lately?

  • K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc. · 2018
  • K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 20112 recalls

All 2 as Philips Healthcare Informatics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K111804IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by…Apr 19, 2019Class II
  • K111804Philips IntelliSpace PACS 4.4 image management systems performs digital image…Jul 24, 2014Class II