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Food law / Radiography / Fluoroscopy / X-ray image intensifier / Federal Food / Drug / and Cosmetic Act / Hologic / Premarket approval / Medical device / Title 21 of the Code of Federal Regulations / Medicine / Health / Food and Drug Administration


Section[removed]k) Summary 1 Manufacturing Establishment and Contact Information
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Document Date: 2012-05-28 00:34:50

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File Size: 160,45 KB

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City

BEDFQRD / Bedford / /

Company

Boyle Regulatory Affairs Specialist 1I1c Hologic Inc. / Performance Testing Software / Kl20388 Trade / Hologic Inc. / Orthoscan Inc. / /

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IndustryTerm

software enhancements / fluoroscopic imaging system / predicate devices / fluoroscopic imaging / x-ray systems / distributed devices / manufacturing / light anatomy imaging situations / software changes / imaging / /

Organization

Food and Drug Administration / /

Person

Eileen M. Boyle / Cosmetic Act (Act) / Ann Fluoroscopic / /

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Position

Director / Major / Affairs Specialist / /

Product

InSight / /

ProvinceOrState

Maryland / Massachusetts / /

Technology

radiation / X-ray / x-ray system / http / CMOIS Flat Detector technology / Flat Detector technology / /

URL

http /

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