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1 102/LU[removed]k) Summary of Safety and Effectiveness 1.5T 16-Channel Hand-Wrist Coil JAN
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Document Date: 2011-02-17 14:36:44

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File Size: 111,94 KB

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City

Ave. Gainesville / /

Company

K103149 Trade / GE / Invivo Corporation / /

Event

FDA Phase / /

/

IndustryTerm

resonance diagnostic device / subject device / magnetic resonance diagnostic device / announcements concerning your device / Internet address http /

Organization

Division of Postmarket Surveillance / office of Device Evaluation / Acting Director Division / FDA / CDRH 's office of Surveillance / In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure Indications for Use / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Radiological Devices Office / /

Person

David G. Brown / /

/

Position

Regulatory Affairs Engineer / physician / Elizabeth Wheeler Regulatory Engineer / /

Product

5T MR scanners / Federal Food / 5T MR / /

ProgrammingLanguage

FL / /

ProvinceOrState

Maryland / Florida / /

Technology

diagnostic imaging / fundamental scientific technology / http / radio frequency / technology of a radio frequency / /

URL

http /

SocialTag