| Device Classification Name |
system, x-ray, mobile
|
| 510(K) Number |
K122697 |
| Device Name |
PORTA 100HF |
| Applicant |
| JOB CORPORATION |
| 1411 w. 190th street |
| suite 120 |
|
gardena,
CA
92048
|
|
| Contact |
takahiro haruyama |
| Regulation Number | 892.1720
|
| Classification Product Code |
|
| Date Received | 09/04/2012 |
| Decision Date | 10/05/2012 |
| 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
|
|
|