Company ยท SE
RaySearch Laboratories AB (PUBL)
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 15 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2025 | K252109 | RayStation (2024A SP3) RaySearch Laboratories AB (PUBL), SE | MUJ |
| Apr 17, 2025 | K242992 | RayCare (2024A SP1) RaySearch Laboratories AB (PUBL), SE | MUJ |
| Apr 4, 2025 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Mar 29, 2023 | K222312 | RayStation 12A RaySearch Laboratories AB (PUBL), SE | MUJ |
| Apr 15, 2022 | K220141 | RayStation 11B RaySearch Laboratories AB (PUBL), SE | MUJ |
| Sep 8, 2021 | K211867 | RayStation 11.0 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Jun 29, 2021 | K210645 | RayStation 10.1 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Sep 24, 2020 | K200569 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
| Jun 10, 2020 | K200487 | RayCare 3.1 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Jul 8, 2019 | K191384 | RayCare 2.3 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Jun 19, 2019 | K190387 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
| Apr 25, 2018 | K180379 | RayStation 7 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Jun 27, 2017 | K171536 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
| Mar 2, 2017 | K170355 | RayStation 6 RaySearch Laboratories AB (PUBL), SE | MUJ |
| Apr 8, 2016 | K160093 | RayStation RaySearch Laboratories AB (PUBL), SE | MUJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||