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FDA 510(k), K083491, NEUROSCAPE
FDA 510(k), K083491, NEUROSCAPE
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510(K) Number: K083491
Device Name: NEUROSCAPE
Manufacturer: NEAL KOLBER
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 11/25/2008
Decision Date: 02/19/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: NEUROSCAPE
Manufacturer: NEAL KOLBER
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 11/25/2008
Decision Date: 02/19/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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