RaySearch Americas Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010034862 | 3010034862 | RaySearch Americas Inc. | 1 | Y | 2026-01-01 | The Empire State Building 350 Fifth Avenue, Suite 5000 Manhattan NY US 10118 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 151452 | 2004713199 | K242992 | RayCare (2024A SP1) | MUJ | 2025-04-17 |
| 151452 | 1267132705 | K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | MUJ | 2025-04-04 |
| 151452 | 1377992400 | K222312 | RayStation 12A | MUJ | 2023-03-29 |
| 151452 | 1227845028 | K220141 | RayStation 11B | MUJ | 2022-04-15 |
| 151452 | 1581770143 | K211867 | RayStation 11.0 | MUJ | 2021-09-08 |
| 151452 | 1249039173 | K210645 | RayStation 10.1 | MUJ | 2021-06-29 |
| 151452 | 1744007575 | K200569 | RayStation | MUJ | 2020-09-24 |
| 151452 | 2057852589 | K200487 | RayCare 3.1 | MUJ | 2020-06-10 |
| 151452 | 1780357001 | K190387 | RayStation | MUJ | 2019-06-19 |
| 151452 | 1331537527 | K180379 | RayStation 7 | MUJ | 2018-04-25 |
| 151452 | 1163627769 | K171536 | RayStation | MUJ | 2017-06-27 |
| 151452 | 1125222552 | K170355 | RayStation 6 | MUJ | 2017-03-02 |
| 151452 | 1870854047 | K160093 | RayStation | MUJ | 2016-04-08 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MUJ | 17 | 2025-04-17 |