RaySearch America Inc

FDA Regulatory Profile

RaySearch America Inc appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0850-2022, Class II) was initiated on February 11, 2022.

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