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Health / Medical device / Federal Food / Drug / and Cosmetic Act / Title 21 of the Code of Federal Regulations / Center for Devices and Radiological Health / Premarket approval / Quality management system / Design controls / Validation / Medicine / Food and Drug Administration / Technology


TOSHIBA Leading Innovation >a> TOSHIBA AMERICA MEDICAL SYSTEMS. INC[removed]Michelle Dimve, TuStin, CA 92780
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Document Date: 2013-12-09 11:45:37

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City

TuStin / TUSTIN CA / /

Company

Regulatory Affairs Toshiba America Medical Systems Inc. / Toshiba Medical Systems Corporation / In Vitro Diagnostics / Toshiba America Medical Systems Inc. / /

Event

FDA Phase / /

Facility

Newv Hamnpshire Avenue Document Control Center / /

IndustryTerm

subject device / Internet address htl /

MarketIndex

TSX 30 / /

OperatingSystem

Windows 7 / Windows XP / /

Organization

Radiological Health Office / Electrotechnical Commission / Newv Hamnpshire Avenue Document Control Center / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Division of Small Manufacturers / International and Consumer Assistance / CDRH's office of Surveillance / /

Person

Paul Biggins / Janine M. Morris / NEMA XR / NEMA PS / /

/

Position

Director / Division / Director / trained and qualified physician / /

Product

Federal Food / /

ProvinceOrState

Maryland / California / /

Technology

Radiation / X-ray / x-ray system / Tomography / http / operating system / 7 Windows XP Subtraction Protocol / /

URL

www.fda._nov/MedicalDcvices/ResourccsforYou/Industry/dcfault.hrn / www.Cda.irov/MedicalDevices/llesourceslborYou/lndusrv/default.uiiin / /

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