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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number892.5050
Classification Product Code
IYE  
Date Received08/27/2012
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
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