| Device Classification Name |
System, Image Processing, Radiological
|
| 510(k) Number |
K881017 |
| Device Name |
DPS-33,000 WITH CENTOR OPTION |
| Applicant |
| Adac Laboratories |
| 540 Alder Dr. |
|
Milpitas,
CA
95035
|
|
| Applicant Contact |
GARY L PEMBROKE |
| Correspondent |
| Adac Laboratories |
| 540 Alder Dr. |
|
Milpitas,
CA
95035
|
|
| Correspondent Contact |
GARY L PEMBROKE |
| Regulation Number | 892.2050 |
| Classification Product Code |
|
| Date Received | 03/10/1988 |
| Decision Date | 08/11/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|