PORTABLE X-RAY SYSTEM


Device Classification Name

unit, x-ray, extraoral with timer

510(k) Number K103600
Device Name PORTABLE X-RAY SYSTEM
Applicant
DIGIMED CORPORATION
1607 n. barclay ave.
buffalo grove, 
IL 
60089

Applicant Contact kim antol
Correspondent
DIGIMED CORPORATION
1607 n. barclay ave.
buffalo grove, 
IL 
60089

Correspodent Contact kim antol
Regulation Number 872.1800
Classification Product Code
EHD  
Date Received 12/08/2010
Decision Date 04/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No