| Device Classification Name |
coil, magnetic resonance, specialty
|
|---|
| 510(K) Number |
K071847 |
|---|
| Device Name |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL |
|---|
| Applicant |
| SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD |
| 6a, building-2, no. 398 |
| tianlin rd |
|
shanghai,
|
|
| Contact |
songtao zhang |
| Regulation Number | 892.1000
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/05/2007 |
|---|
| Decision Date | 07/23/2007 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Radiology
|
|---|
| Review Advisory Committee |
Radiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
Yes
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
