OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)


Device Classification Name

system,planning,radiation therapy treatment

510(k) Number K081281
Device Name OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
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 05/06/2008
Decision Date 05/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls