ONCENTRA PROSTATE 4.0


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K112420
Device Name ONCENTRA PROSTATE 4.0
Applicant
NUCLETRON
7021 columbia gateway drive
suite 200
columbia, 
MD 
21046

Applicant Contact michael paul
Correspondent
NUCLETRON
7021 columbia gateway drive
suite 200
columbia, 
MD 
21046

Correspodent Contact michael paul
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 08/23/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No