VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K111973
Device Name VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
Applicant
NUCLETRON
7021 columbia gateway dr
suite 200
columbia, 
MD 
21046

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

Correspodent Contact michael paul
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 07/12/2011
Decision Date 09/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No