Device Classification Name |
Camera, Multi Format, Radiological
|
510(k) Number |
K972163 |
Device Name |
IMATION SE-196 LASER IMAGER |
Applicant |
IMATION CORP. |
1 IMATION PLACE |
OAKDALE,
MN
55128
|
|
Applicant Contact |
STEPHEN G SLAVENS |
Correspondent |
IMATION CORP. |
1 IMATION PLACE |
OAKDALE,
MN
55128
|
|
Correspondent Contact |
STEPHEN G SLAVENS |
Regulation Number | 892.2040
|
Classification Product Code |
|
Date Received | 06/09/1997 |
Decision Date | 09/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|