Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K023772 |
Device Name |
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
Applicant |
ACUSON CORP. |
1230 SHOREBIRD WAY |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
BOB LEIKER |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/12/2002 |
Decision Date | 11/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|