MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K021286
Device Name MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
Original Applicant
NUCLETRON CORP.
7080 columbia gateway dr.
columbia, 
MD 
21046

Original Contact lisa dimmick
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 04/23/2002
Decision Date 05/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No