| Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
|---|
| 510(K) Number |
K122866 |
|---|
| Models |
FXRD-1417B,
FXRD-1717SA, FXRD-1717SB, FXRD-1417SA
|
| Device Name |
VIVIX-S WITH VXVUE |
|---|
| Applicant |
| VIEWORKS CO., LTD. |
| 951 starbuck st |
| unit j |
|
fullerton,
CA
92833
|
|
| Contact |
priscilla chung |
| Regulation Number | 892.1650
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/18/2012 |
|---|
| Decision Date | 01/11/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
