RAYSTATION
FDA 510(k) clearance K120387 · decided 2012-04-06
Clearance details
- K-number
- K120387
- Device name
- RAYSTATION
- Applicant
- Raysearch Laboratories AB
- Decision
- Substantially Equivalent
- Date received
- 2012-02-07
- Decision date
- 2012-04-06
- Days to decision
- 59 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 |
|---|---|---|
| RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: Ray recall (Z-1679-2015) | RAYSEARCH LABORATORIES AB | 2015-05-27 |
| 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 |
| Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 recall (Z-0281-2014) | RAYSEARCH LABORATORIES AB | 2013-11-14 |
| RayStation Therapy Treatment Planning System, Model Numbers 2.0, 2.5, and 3.0; CLASSIFICAT recall (Z-1419-2013) | RAYSEARCH LABORATORIES AB | 2013-05-28 |
| Brand name: RayStation. Generic name: Treatment Planning System. Software version and buil recall (Z-2324-2012) | RAYSEARCH LABORATORIES AB | 2012-09-06 |