| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K930997 |
| Device Name |
DOMINATOR RADIOLOGY SYSTEM |
| Applicant |
| Dominator Radiology Systems, Inc. |
| P.O. Box 3784 |
|
Rancho Santa Fe,
CA
92067
|
|
| Applicant Contact |
MURRY A REICHER |
| Correspondent |
| Dominator Radiology Systems, Inc. |
| P.O. Box 3784 |
|
Rancho Santa Fe,
CA
92067
|
|
| Correspondent Contact |
MURRY A REICHER |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 02/01/1993 |
| Decision Date | 04/07/1993 |
| 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
|
|
|