Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K921008 |
Device Name |
VECTOR SERIES |
Applicant |
SOPHA MEDICAL SYSTEMS, INC. |
7155 COLUMBIA GATEWAY DR. |
COLUMBIA,
MD
21046 -2101
|
|
Applicant Contact |
RANDY L WEATHERHEAD |
Correspondent |
SOPHA MEDICAL SYSTEMS, INC. |
7155 COLUMBIA GATEWAY DR. |
COLUMBIA,
MD
21046 -2101
|
|
Correspondent Contact |
RANDY L WEATHERHEAD |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 03/03/1992 |
Decision Date | 04/27/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|