Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K971878 |
Device Name |
VANTAGE 2.1 EXSPECT |
Applicant |
ADAC LABORATORIES |
540 ALDER DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
DENNIS W HENKELMAN |
Correspondent |
ADAC LABORATORIES |
540 ALDER DR. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
DENNIS W HENKELMAN |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 05/21/1997 |
Decision Date | 08/08/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|