RAYSTATION VERSION 1.0— 510(k) K100552
Substantially EquivalentRaysearch Laboratories AB
FDA 510(k) clearance K100552 for RAYSTATION VERSION 1.0, Substantially Equivalent on 2010-03-12. Applicant: Raysearch Laboratories AB. Device class: 2.
Clearance details
- Applicant
- Raysearch Laboratories AB
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code MUJ
view allMore clearances from Raysearch Laboratories AB
view allRecalls naming K100552
K-number listed on FDA's recall record- Z-1481-2014 — RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
- Z-1307-2014 — RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100552.
Data sourced from openFDA. This site is unofficial and independent of the FDA.