RAYSTATION VERSION 1.0
FDA 510(k) clearance K100552 · decided 2010-03-12
Clearance details
- K-number
- K100552
- Device name
- RAYSTATION VERSION 1.0
- Applicant
- Raysearch Laboratories AB
- Decision
- Substantially Equivalent
- Date received
- 2010-02-26
- Decision date
- 2010-03-12
- Days to decision
- 14 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
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. V recall (Z-1481-2014) | RAYSEARCH LABORATORIES AB | 2014-04-21 |
| RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a so recall (Z-1307-2014) | RAYSEARCH LABORATORIES AB | 2014-03-28 |
| RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Labora recall (Z-1317-2012) | RAYSEARCH LABORATORIES AB | 2012-03-26 |
| RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavag recall (Z-0359-2012) | RAYSEARCH LABORATORIES AB | 2011-12-02 |