| 510(k) Number |
K827572 |
| Device Name |
ADAC MODEL DPS-6100 MULTI MODALITY DIGITAL PROCESING SYSTEMS |
| Applicant |
| Adac Laboratories |
| Jellingvej 5 |
| 9230 Svenstrup |
|
Denmark,
DK
|
|
| Correspondent |
| Adac Laboratories |
| Jellingvej 5 |
| 9230 Svenstrup |
|
Denmark,
DK
|
|
| Date Received | 06/01/1982 |
| Decision Date | 07/09/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|