| Device Classification Name |
System, Digital Image Communications, Radiological
|
| 510(k) Number |
K980684 |
| Device Name |
VR NETSERVE |
| Applicant |
| I.S.G. Technologies, Inc. |
| 6509 Airport Rd. |
|
Mississauga Ontario,
CA
L4V 1S7
|
|
| Applicant Contact |
CAROL NAKAGAWA |
| Correspondent |
| I.S.G. Technologies, Inc. |
| 6509 Airport Rd. |
|
Mississauga Ontario,
CA
L4V 1S7
|
|
| Correspondent Contact |
CAROL NAKAGAWA |
| Regulation Number | 892.2020 |
| Classification Product Code |
|
| Date Received | 02/23/1998 |
| Decision Date | 05/06/1998 |
| 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
|
|
|