LR DICOM CONTROLLER


Device Classification Name

camera, multi format, radiological

510(k) Number K022658
Device Name LR DICOM CONTROLLER
Original Applicant
AGFA CORP.
10 south academy st.
greenville, 
SC 
29601

Original Contact jeff jedlicka
Regulation Number 892.2040
Classification Product Code
LMC  
Date Received 08/09/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No