Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list RaySearch Laboratories and its 1 subsidiaries with 117 device recalls, 22 510(k) clearances and 8 AI-enabled devices. The most recent is a 510(k) clearance dated Dec 22, 2025: RayStation (2024A SP3).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, RaySearch Laboratories and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 22, 2025 | RayStation (2024A SP3)K252109 · MUJ | 510(k) clearances |
| Apr 17, 2025 | RayCare (2024A SP1)K242992 · MUJ | 510(k) clearances |
| Apr 4, 2025 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3K240398 · MUJ | 510(k) clearances |
| Apr 4, 2025 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3K240398 · Radiology | AI-enabled devices |
| Mar 29, 2023 | RayStation 12AK222312 · MUJ | 510(k) clearances |
| Mar 29, 2023 | RayStation 12AK222312 · Radiology | AI-enabled devices |
| Apr 15, 2022 | RayStation 11BK220141 · MUJ | 510(k) clearances |
| Apr 15, 2022 | RayStation 11BK220141 · Radiology | AI-enabled devices |
| Feb 11, 2022 | RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.3Class II · Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. | Device recalls |
| Sep 8, 2021 | RayStation 11.0K211867 · MUJ | 510(k) clearances |
| Sep 8, 2021 | RayStation 11.0K211867 · Radiology | AI-enabled devices |
| Jun 29, 2021 | RayStation 10.1K210645 · MUJ | 510(k) clearances |
| Jun 29, 2021 | RayStation 10.1K210645 · Radiology | AI-enabled devices |
| Jan 22, 2021 | Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10AClass II · A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wa | Device recalls |
| Sep 24, 2020 | RayStationK200569 · MUJ | 510(k) clearances |
| Sep 24, 2020 | RayStationK200569 · Radiology | AI-enabled devices |
| Jul 8, 2019 | RayCare 2.3K191384 · Radiology | AI-enabled devices |
| Jun 19, 2019 | RayStationK190387 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
