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Food and Drug Administration / Medical imaging / Telehealth / Multi-touch / Tablet computers / Picture archiving and communication system / Medical device / Premarket approval / IPad / Medicine / Health / Technology


APR[removed]e l Carestream Garestreamn Health Inc.
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Document Date: 2014-05-07 12:37:02


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City

Rochester / Verona / /

Company

Carestreamn Health Inc. / Kl40271 Trade / Carestrearn Health Inc. / Coirestream Carestreamn Health Inc. / Ki40271 Device Name CARESTREAM Tablet Viewer Software / Image Suite / In Vitro Diagnostics / CARESTREAM Tablet Viewer Software / Tablet Viewer Software / Carestream Garestreamn Health Inc. / /

Country

United States / /

/

Event

FDA Phase / /

Facility

Communication System Device Class / /

/

IndustryTerm

fundamental tools / firomn web browsers / wireless network / validated mobile devices / web browsers / software technology / predicate device / manufacturing practice requirements / validated mobile device / mammography applications / Internet address littp /

NaturalFeature

and Drug Administration Expiration Dale / /

Organization

Radiological Health Office / Food and Drug Administration / Center for Devices / Radiological Health Center for Devices and Radiological Health Enclosure Food and Drug Administration Expiration Dale / PACS / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /

Person

Alexandra Chamberlain / Janine M. Morris / Alexandra ChamberlainRegulatory / /

/

Position

Director / Division / Manager 150 Verona Street ROCHESTER NY / Regulatory Affairs Manager / General / Affairs Manager / Manager alexandra.chamberlain@carestream.com / /

Product

Apple iPad / iPad / Ki40271 Device Name CARESTREAM Tablet / CARESTREAM Tablet / Federal Food / /

ProvinceOrState

New York / /

Technology

radiation / software technology / mobile device / Image Processing / mobile devices / GUI / /

URL

www.tdia.qov/McdicalDcviccs/Sai~tv/RcporaPi'oblcin/dcfbilt.htrn / /

SocialTag