FDA 510(k), K111914, VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM

FDA 510(k), K111914, VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM

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510(K) Number: K111914
Device Name: VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
Manufacturer: SHERI L MUSGNUNG
Device Classification Name: Automated Digital Image Manual Interpretation Microscope
Regulation Number: OEO
Classification Product Code: KXA
Date Received: 07/06/2011
Decision Date: 08/21/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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