Device Classification Name |
System, Digital Image Communications, Radiological
|
510(k) Number |
K974102 |
Device Name |
MILTRA IMAGING INC., IMAGE VAULT |
Applicant |
MITRA IMAGING, INC. |
16303 PANORAMIC WAY |
SAN LEANDRO,
CA
94578 -1116
|
|
Applicant Contact |
GARY J ALLSEBROOK |
Correspondent |
MITRA IMAGING, INC. |
16303 PANORAMIC WAY |
SAN LEANDRO,
CA
94578 -1116
|
|
Correspondent Contact |
GARY J ALLSEBROOK |
Regulation Number | 892.2020
|
Classification Product Code |
|
Date Received | 10/31/1997 |
Decision Date | 01/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|