REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K022739
Device Name REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002
Original Applicant
NUCLETRON CORPORATION
7080 columbia gateway dr.
columbia, 
MD 
21046 -2133

Original Contact lisa dimmick
Regulation Number 892.5700
Classification Product Code
JAQ  
Subsequent Product Code
MUJ  
Date Received 08/19/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No