Device Classification Name |
system, image processing, radiological |
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---|---|---|---|---|---|
510(k) Number | K121213 | ||||
Device Name | VITREAADVANCED | ||||
Applicant |
|
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Applicant Contact | daniel biank | ||||
Correspondent |
|
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Correspodent Contact | daniel biank | ||||
Regulation Number | 892.2050 | ||||
Classification Product Code |
|
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Date Received | 04/20/2012 | ||||
Decision Date | 11/02/2012 | ||||
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 |
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Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |
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Recalls | CDRH Recalls |