| Device Classification Name |
system,x-ray,extraoral source,digital
|
|---|
| 510(K) Number |
K112380 |
|---|
| Model |
XSDS-01, XSDS-02, XSDN-01, XSDN-02
|
| Device Name |
CLEARVISION |
|---|
| Applicant |
| MIDMARK CORP. |
| 675 heathrow drive |
|
lincolnshire,
IL
60069
|
|
| Contact |
lisa bartakovics |
| Regulation Number | 872.1800
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/17/2011 |
|---|
| Decision Date | 11/22/2011 |
|---|
| 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
|
|---|
|
|
