Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K791055 |
Device Name |
ADAC TOMOGRAPHY OPTION |
Applicant |
ADAC LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ADAC LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 06/07/1979 |
Decision Date | 09/17/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|