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 |
Applicant |
AGFA CORP. |
PO BOX 1927 |
BREVARD,
NC
28712
|
|
Applicant Contact |
DAVID LEDWIG |
Correspondent |
AGFA CORP. |
PO BOX 1927 |
BREVARD,
NC
28712
|
|
Correspondent Contact |
DAVID LEDWIG |
Regulation Number | 892.2050
|
Classification Product Code |
|
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
|
|
|