Viewray, Inc.

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1836-2021Class IIViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be May 4, 2021
Z-0482-2021Class IIViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - FrequencOctober 20, 2020
Z-0481-2021Class IIViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency RangOctober 20, 2020
Z-1803-2020Class IIViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System TreatmenNovember 18, 2019
Z-1251-2019Class IIMRIdian Linac Radiation Therapy System, Model 20000.March 18, 2019
Z-0676-2020Class IIMRIdian Linac Radiation Therapy System Model 10000 and 20000March 3, 2019