INTEGRATED BRACHYTHERAPY UNIT – DIGITAL


Device Classification Name

system, simulation, radiation therapy

510(k) Number K072445
Device Name INTEGRATED BRACHYTHERAPY UNIT – DIGITAL
Applicant
NUCLETRON CORP.
8671 robert fulton drive
columbia, 
MD 
21046

Applicant Contact lisa dimmick
Correspondent
NUCLETRON CORP.
8671 robert fulton drive
columbia, 
MD 
21046

Correspodent Contact lisa dimmick
Regulation Number 892.5840
Classification Product Code
KPQ  
Date Received 08/30/2007
Decision Date 09/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No