FDA applicant

Raysearch Laboratories AB

Stockholm, SE7 decisions2008–201417 recalls

FDA records 7 decisions for Raysearch Laboratories AB (Stockholm, SE) from 2008 to 2014: 7 510(k) clearances. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 13 predicates, 5 of them its own earlier devices. 17 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 Raysearch Laboratories AB’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2008high 2 (2014) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2025

2008high 4 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Raysearch Laboratories AB by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Raysearch Laboratories AB’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

Other applicant names beginning “Raysearch”

FDA records each applicant name separately; these may or may not be the same firm.

RaySearch Laboratories AB (PUBL) 15

Raysearch Laboratories AB

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Raysearch”