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FDA 510(k), K161148, icobrain
FDA 510(k), K161148, icobrain
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510(K) Number: K161148
Device Name: icobrain
Manufacturer: Dirk Loeckx
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 04/22/2016
Date Received: 08/09/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: icobrain
Manufacturer: Dirk Loeckx
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: 04/22/2016
Date Received: 08/09/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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