RAYSTATION
FDA 510(k) clearance K141860 · decided 2014-10-23
Clearance details
- K-number
- K141860
- Device name
- RAYSTATION
- Applicant
- Raysearch Laboratories AB
- Decision
- Substantially Equivalent
- Date received
- 2014-07-10
- Decision date
- 2014-10-23
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Stockholm, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Ca recall (Z-1195-2025) | RAYSEARCH LABORATORIES AB | 2025-02-19 |
| RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4 recall (Z-1712-2016) | RAYSEARCH LABORATORIES AB | 2016-05-25 |
| Radiation Therapy Treatment Planning System software RayStation is a software system desig recall (Z-2785-2015) | RAYSEARCH LABORATORIES AB | 2015-09-17 |
| RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning recall (Z-2457-2015) | RAYSEARCH LABORATORIES AB | 2015-08-25 |
| RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, recall (Z-1310-2015) | RAYSEARCH LABORATORIES AB | 2015-03-20 |