VIEWRAY SYSTEM


Device Classification Name

accelerator, linear, medical

510(k) Number K111862
Device Name VIEWRAY SYSTEM
Applicant
VIEWRAY INCORPORATED
2 thermofisher way
oakwood, 
OH 
44146

Applicant Contact janice brownlee
Correspondent
VIEWRAY INCORPORATED
2 thermofisher way
oakwood, 
OH 
44146

Correspodent Contact janice brownlee
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 06/30/2011
Decision Date 05/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls