ONCENTRA GYN


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K080929
Device Name ONCENTRA GYN
Applicant
NUCLETRON CORPORATION
8671 robert fulton dr.
columbia, 
MD 
21046 -2133

Applicant Contact lisa dimmick
Regulation Number 892.5050
Classification Product Code
MUJ  
Date Received 04/01/2008
Decision Date 04/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No