RaySearch America Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0850-2022Class IIRayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) tFebruary 11, 2022
Z-2039-2023Class IIRadiation therapy software, RayStation standalone software treatment planning system. Model numbers:January 22, 2021