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Tumor suppressor genes / Apoptosis / Programmed cell death / P53 / Immunohistochemistry / Digital pathology / Biology / Medicine / Proteins


K121350 Ventana Virtuoso for LHC p53 (DO-7) for Benchmark Ultra[removed]k) Summary 510(k) Summary[removed]a)(1): Name: Address: Phone:
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Document Date: 2012-07-06 14:45:25

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City

Sunnyvale / Altos / /

Company

System Operation (Digital Read and Image Analysis) Hardware / Ammirati Regulatory Consulting / Ventana Medical Systems Inc. / HUMAN SERVICES Ventana Medical Systems Inc. / /

Event

FDA Phase / /

Facility

Court Sunnyvale / /

IndustryTerm

test systems / iScan slide scanning device / digital pathology software solution / image analysis systems / announcements concerning your device / scanner software / instrument-plus-software system / software application score / manufacturing practice requirements / image analysis applications / windows web browser / image analysis algorithms / software makes / marketed predicate devices / manufacturing practice / /

MarketIndex

DAB / ULTRA / /

OperatingSystem

Microsoft Windows / /

Organization

Food and Drug Administration / DEPARTMENT OF HEALTH / /

Person

Erika B. Ammirati / /

/

Position

Virtuoso Digital Read vs Manual Method Each pathologist / qualified pathologist / pathologist / p53 Intra-Pathologist / same pathologist / General / vs Pathologist / qualified pathologist in the acquisition / /

Product

F15 / Federal Food / /

ProvinceOrState

Maryland / California / /

Technology

image analysis algorithms / Dav / /

SocialTag