# RaySearch Laboratories AB (PUBL)

- Location (FDA's records): Stockholm, SE
- FDA decisions: 15 (2016–2025): 15 510(k) clearances
- Product codes: MUJ (15)
- 510(k) review time since 2016: median 104 days, against 87 for FDA's reviews in the same codes and years (5 of 15 faster)
- Predicates its devices cite: 17 (13 its own); citations of its devices by later devices: 15 (13 its own)
- Recalls linked to its devices: 96 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Raysearch Laboratories AB: 1 (https://510kreport.com/company/raysearch-laboratories)
- Elekta, Ltd.: 1 (https://510kreport.com/company/elekta)
- Elekta Solutions AB: 1 (https://510kreport.com/company/elekta-solutions)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)

## Firms that cite its devices most
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Elekta Solutions AB: 1 (https://510kreport.com/company/elekta-solutions)

## Its most-cited devices
- K170355: RayStation 6 (2017), cited by 2
- K190387: RayStation (2019), cited by 2
- K200487: RayCare 3.1 (2020), cited by 1
- K160093: RayStation (2016), cited by 1
- K240398: RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (2025), cited by 1
- K222312: RayStation 12A (2023), cited by 1

## Recent decisions
- K252109: RayStation (2024A SP3) (Dec 22, 2025)
- K242992: RayCare (2024A SP1) (Apr 17, 2025)
- K240398: RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 (Apr 4, 2025)
- K222312: RayStation 12A (Mar 29, 2023)
- K220141: RayStation 11B (Apr 15, 2022)
- K211867: RayStation 11.0 (Sep 8, 2021)
- K210645: RayStation 10.1 (Jun 29, 2021)
- K200569: RayStation (Sep 24, 2020)

Source page: https://510kreport.com/company/raysearch-laboratories-ab-publ