Device Classification Name |
system, x-ray, mammographic
|
510(k) Number |
K000976 |
Device Name |
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) |
Applicant |
INSTRUMENTARIUM IMAGING, INC. |
300 WEST EDGERTON AVE. |
MILWAUKEE,
WI
53207 -6025
|
|
Applicant Contact |
MAX LINDERT |
Correspondent |
INSTRUMENTARIUM IMAGING, INC. |
300 WEST EDGERTON AVE. |
MILWAUKEE,
WI
53207 -6025
|
|
Correspondent Contact |
MAX LINDERT |
Regulation Number | 892.1710
|
Classification Product Code |
|
Date Received | 03/27/2000 |
Decision Date | 06/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|