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