| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K970641 |
| Device Name |
RIS SCANVIEW SYSTEM (RSVS) |
| Applicant |
| Radiology Information Systems, Inc. |
| 2004 Adams Hill Rd. |
|
Vienna,
VA
22182
|
|
| Applicant Contact |
JOE S PI |
| Correspondent |
| Radiology Information Systems, Inc. |
| 2004 Adams Hill Rd. |
|
Vienna,
VA
22182
|
|
| Correspondent Contact |
JOE S PI |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 02/20/1997 |
| Decision Date | 05/02/1997 |
| 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
|
|
|