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 / /