Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K031872 |
Device Name |
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] |
Applicant |
ADAC LABORATORIES |
540 ALDER DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
CHARLENE BRUMBAUGH |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1655 SCOTT BLVD. |
SANTA CLARA,
CA
95050
|
|
Correspondent Contact |
MORTEN CHRISTENSEN |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 06/17/2003 |
Decision Date | 06/20/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|