Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K942837 |
Device Name |
DST-XL |
Applicant |
SOPHA MEDICAL SYSTEMS, INC. |
7155 COLUMBIA GATEWAY DR. |
COLUMBIA,
MD
21046 -2101
|
|
Applicant Contact |
COLIN J MCNAUGHT |
Correspondent |
SOPHA MEDICAL SYSTEMS, INC. |
7155 COLUMBIA GATEWAY DR. |
COLUMBIA,
MD
21046 -2101
|
|
Correspondent Contact |
COLIN J MCNAUGHT |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 06/15/1994 |
Decision Date | 01/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|