RAYSTATION— 510(k) K130617

Clearance details

Applicant

Raysearch Laboratories AB

Product code

Code MUJ

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2013-03-07

Decision date

2013-05-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stockholm, SE

• K260750 — Virtual Cone (1.0)2026-07-08
• K253050 — RadOncAI2026-06-18
• K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
• K252784 — eXaSkin Plus2026-05-22
• K253078 — ART.1-US2026-05-14

• K141860 — RAYSTATION2014-10-23
• K140187 — RAY STATION2014-05-15
• K120387 — RAYSTATION2012-04-06
• K100552 — RAYSTATION VERSION 1.02010-03-12
• K083264 — RAYAUTOPLAN 1.02009-01-22

• Z-1679-2015 — RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: 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. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.Class II·Terminated·RAYSEARCH LABORATORIES AB·20150508
• Z-1806-2014 — RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.Class II·Terminated·RAYSEARCH LABORATORIES AB·20140425
• 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.Class II·Terminated·RAYSEARCH LABORATORIES AB·20140214
• 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.Class II·Terminated·RAYSEARCH LABORATORIES AB·20140206
• Z-1308-2014 — RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone softwareClass II·Terminated·RAYSEARCH LABORATORIES AB·20140206
• Z-0281-2014 — Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0Class II·Terminated·RAYSEARCH LABORATORIES AB·20131023

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130617.