RAYSTATION— 510(k) K141860
Substantially EquivalentRaysearch Laboratories AB
FDA 510(k) clearance K141860 for RAYSTATION, Substantially Equivalent on 2014-10-23. 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 K141860
K-number listed on FDA's recall record- Z-1195-2025 — Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
- Z-1712-2016 — RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
- Z-2785-2015 — Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
- Z-2457-2015 — RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
- Z-1310-2015 — RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is 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 K141860.
Data sourced from openFDA. This site is unofficial and independent of the FDA.