FDA applicant
RaySearch Laboratories AB (PUBL)
FDA records 15 decisions for RaySearch Laboratories AB (PUBL) (Stockholm, SE) from 2016 to 2025: 15 510(k) clearances. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 13 of them its own earlier devices. 96 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided RaySearch Laboratories AB (PUBL)’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like RaySearch Laboratories AB (PUBL)’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) ReportOther applicant names beginning “RaySearch”
FDA records each applicant name separately; these may or may not be the same firm.