RAYSEARCH LABORATORIES AB

FDA Regulatory Profile

Summary

Total Recalls
113
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1107-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software VerNovember 28, 2025
Z-1106-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1November 28, 2025
Z-1105-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.November 28, 2025
Z-1108-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 SoftNovember 28, 2025
Z-1103-2026Class IIRayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStaNovember 28, 2025
Z-1109-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software VerNovember 28, 2025
Z-1104-2026Class IIRayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software VersioNovember 28, 2025
Z-1110-2026Class IIBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 SoftNovember 28, 2025
Z-1102-2026Class IIRayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. RadiaNovember 28, 2025
Z-2495-2025Class IIRayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.August 8, 2025
Z-2487-2025Class IIRayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19.August 8, 2025
Z-2491-2025Class IIRayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.August 8, 2025
Z-2492-2025Class IIRayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.August 8, 2025
Z-2489-2025Class IIRayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.93August 8, 2025
Z-2493-2025Class IIRayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.August 8, 2025
Z-2488-2025Class IIRayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47August 8, 2025
Z-2494-2025Class IIRayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software VerAugust 8, 2025
Z-2490-2025Class IIRayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.August 8, 2025
Z-1189-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog NumJanuary 16, 2025
Z-1191-2025Class IIBrand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog NumJanuary 16, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K141860RAYSTATIONOctober 23, 2014
K140187RAY STATIONMay 15, 2014
K130617RAYSTATIONMay 10, 2013
K120387RAYSTATIONApril 6, 2012
K100552RAYSTATION VERSION 1.0March 12, 2010
K083264RAYAUTOPLAN 1.0January 22, 2009
K082221RAYDOSEOctober 22, 2008