510(k) Report

FDA applicant

Philips Nuclear Medicine, Inc.

Milpitas, CA1 decision2008–20081 recall

FDA records 1 decision for Philips Nuclear Medicine, Inc. (Milpitas, CA) in 2008: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is 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 Nuclear Medicine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2008high 1 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Philips Nuclear Medicine, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K080961NM Application SuitePhilips Nuclear Medicine, Inc. · 20083cite it

What has FDA decided for it lately?

  • K080961NM Application SuitePhilips Nuclear Medicine, Inc. · 20081 recall

The one decision as Philips Nuclear Medicine, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K012009Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H…Sep 15, 2011