Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K980867 |
Device Name |
3D-MSPECT |
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 | 03/06/1998 |
Decision Date | 06/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|