Data / Medical devices / United States / RaySearch Americas Inc.
RaySearch Americas Inc.: FDA-registered device maker in Manhattan, NY, United States, 12 510(k) clearances
RaySearch Americas Inc. is registered with the FDA (registration 3010034862) in Manhattan, NY, United States. It lists 1 device type. The FDA files 12 510(k) clearances under its listings, the newest dated April 17, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010034862
- Address
- The Empire State Building 350 Fifth Avenue, Suite 5000, Manhattan, NY, United States, 10118
- Owner or operator
- RaySearch Laboratories AB (publ) (10029973)
- Roles
- Complaint file establishment
- First device listed
- March 23, 2017
- Registered through
- 2026
- Brand names listed
- RayCare 2024A SP1, RayCare 3.1, RayPlan 10A, RayPlan 10B, RayPlan 11A, RayPlan 11B, RayPlan 12A, RayPlan 2023B and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 17, 2025 | K242992 | RayCare (2024A SP1) | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| April 4, 2025 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| March 29, 2023 | K222312 | RayStation 12A | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| April 15, 2022 | K220141 | RayStation 11B | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| September 8, 2021 | K211867 | RayStation 11.0 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 29, 2021 | K210645 | RayStation 10.1 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| September 24, 2020 | K200569 | RayStation | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 10, 2020 | K200487 | RayCare 3.1 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 19, 2019 | K190387 | RayStation | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| April 25, 2018 | K180379 | RayStation 7 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| June 27, 2017 | K171536 | RayStation | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
| March 2, 2017 | K170355 | RayStation 6 | MUJ | Substantially Equivalent | RaySearch Laboratories AB (PUBL) | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 11, 2022 | 89822 | Class II | Ongoing | 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 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayS | Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. | accessdata.fda.gov |
| January 22, 2021 | 92441 | Class II | Terminated | Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. | A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inapp | accessdata.fda.gov |
Compare with other makers
Updated April 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.