Viewray Incorporated

FDA Regulatory Profile

Summary

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

Known Names

viewray incorporated, viewray, incorporated

Recent Recalls

NumberClassProductDate
Z-1309-2016Class IIMRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also knownMarch 7, 2016
Z-0806-2016Class IIMRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.December 24, 2015
Z-0115-2016Class IIMRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery August 27, 2015
Z-1954-2015Class IITreatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotacticMay 7, 2015
Z-2085-2015Class IIPatient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic raApril 1, 2015
Z-1580-2015Class IIViewRay System, Radiation Therapy SystemJanuary 15, 2015