IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO


Device Classification Name

system, image processing, radiological

510(k) Number K022292
Device Name IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
Original Applicant
AGFA CORP.
po box 1927
brevard, 
NC 
28712

Original Contact david ledwig
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/15/2002
Decision Date 09/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls