| Device Classification Name |
system, nuclear magnetic resonance imaging |
|||
|---|---|---|---|---|
| 510(k) Number | K081028 | |||
| Device Name | SIGNA 3.0T MR750 SYSTEM | |||
| Applicant |
|
|||
| Applicant Contact | mark stauffer | |||
| Regulation Number | 892.1000 | |||
| Classification Product Code |
|
|||
| Date Received | 04/11/2008 | |||
| Decision Date | 04/25/2008 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Radiology |
|||
| 510k Review Panel |
Radiology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | Yes | |||
| Combination Product |
No |
|||
| Recalls | CDRH Recalls |