EPIGRAY


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K112723
Device Name EPIGRAY
Applicant
DOSISOFT SA
1244 fairway valley court
lincoln, 
CA 
95648

Applicant Contact robert j morton
Correspondent
DOSLSOFT SA
1244 fairway valley court
lincoln, 
CA 
95648

Correspodent Contact robert j morton
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 09/19/2011
Decision Date 02/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No