Device Classification Name |
system, image processing, radiological |
|||
---|---|---|---|---|
510(k) Number | K121916 | |||
Device Name | INTUITION | |||
Applicant |
|
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Applicant Contact | robert taylor | |||
Correspondent |
|
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Correspodent Contact | robert taylor | |||
Regulation Number | 892.2050 | |||
Classification Product Code |
|
|||
Date Received | 07/02/2012 | |||
Decision Date | 04/02/2013 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Radiology |
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510k Review Panel |
Radiology |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
|||
Recalls | CDRH Recalls |