| Device Classification Name |
system, nuclear magnetic resonance imaging |
|||
|---|---|---|---|---|
| 510(k) Number | K111226 | |||
| Device Name | ENDOSCOUT TRACKING SYSTEM | |||
| Applicant |
|
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| Applicant Contact | raymond kelly | |||
| Correspondent |
|
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| Correspodent Contact | raymond kelly | |||
| Regulation Number | 892.1000 | |||
| Classification Product Code |
|
|||
| Date Received | 05/02/2011 | |||
| Decision Date | 07/01/2011 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Radiology |
|||
| 510k Review Panel |
Radiology |
|||
| statement |
statement |
|||
| Type | Special | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |