PANTHER OIS/R & V MODEL VERSION 2.0


Device Classification Name

accelerator, linear, medical

510(k) Number K122616
Device Name PANTHER OIS/R & V MODEL VERSION 2.0
Applicant
PROWESS, INC.
1844 clayton road
concord, 
CA 
94520

Applicant Contact rachel scarano
Correspondent
PROWESS, INC.
1844 clayton road
concord, 
CA 
94520

Correspodent Contact rachel scarano
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 08/27/2012
Decision Date 12/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No