| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K955708 |
| Device Name |
COMPUMED DICON CLIENT |
| Applicant |
| COMPUMED, INC. |
| 2245 FRANKLIN AVE. |
|
MEETEETSE,
WY
82433
|
|
| Correspondent |
| COMPUMED, INC. |
| 2245 FRANKLIN AVE. |
|
MEETEETSE,
WY
82433
|
|
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 12/14/1995 |
| Decision Date | 03/01/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|