Raysearch Laboratories AB: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Raysearch Laboratories AB” (first 2008, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 59 |
| 2013 | 1 | 64 |
| 2014 | 2 | 108 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 7 | 7 |
Review panels
- Radiology (7)
Most recent Raysearch Laboratories AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141860 | RAYSTATION | MUJ | 2014-10-23 | 105 |
| K140187 | RAY STATION | MUJ | 2014-05-15 | 111 |
| K130617 | RAYSTATION | MUJ | 2013-05-10 | 64 |
| K120387 | RAYSTATION | MUJ | 2012-04-06 | 59 |
| K100552 | RAYSTATION VERSION 1.0 | MUJ | 2010-03-12 | 14 |
| K083264 | RAYAUTOPLAN 1.0 | MUJ | 2009-01-22 | 78 |
| K082221 | RAYDOSE | MUJ | 2008-10-22 | 77 |
Recalls
117 product recalls in 59 recall events; 50 initiated in the last five years. Most recent: 2026-05-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- RaySearch Laboratories AB (PUBL) (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Raysearch Laboratories AB?
FDA lists 7 510(k) clearances under the applicant name “Raysearch Laboratories AB” (first 2008, latest 2014), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Raysearch Laboratories AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Raysearch Laboratories AB is 77 days.
Which FDA product codes appear under Raysearch Laboratories AB?
The most frequent FDA product codes under this applicant name are MUJ (System, Planning, Radiation Therapy Treatment, 7).
Next steps
- See all 7 Raysearch Laboratories AB clearances with predicates and recalls
- Run predicate analysis for product code MUJ, Raysearch Laboratories AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.