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Medical imaging / Medical physics / Orthopantomogram / Planmeca / Dental radiography / X-ray image intensifier / Radiology / Title 21 of the Code of Federal Regulations / X-ray / Medicine / Projectional radiography / Radiography


g (.2~IS 510(k) Summary JAN[removed]
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Document Date: 2013-02-06 08:16:26


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City

Heathrow Drive Lincolnshire / Lincolnshire / /

Company

Midmnark Company / K122643 Trade / Radiological Health / In Vitro Diagnostics / Midlmark Corporation / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

linear tomography imaging principle / extraoral radiographic imaging system / announcements concerning your device / predicate devices / dental xray equipment / manufacturing practice requirements / marketed predicate devices / manufacturing practice / marketed devices / /

MedicalCondition

diseases / /

MedicalTreatment

radiation / /

Organization

Radiological Health Office / Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use / FDA / DEPARTMENT OF HEALTH / /

Person

Janine M. Morris / Mark Greenwood / /

/

Position

Director / Engineering and Product Development / Director / Division / /

Product

Federal Food / /

ProvinceOrState

Maryland / Illinois / /

Technology

radiation / x-ray / X-Ray System / tomography / /

URL

http /

SocialTag