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Medical equipment / Medical imaging / RSA / DICOM / Title 21 of the Code of Federal Regulations / Center for Devices and Radiological Health / Medicine / Medical technology / Medical device


510(k) Summary K[removed]Halifax Biomedical Inc.V[removed]Route 19, Mabou Nova Scotia, Canada, BOE iXO +[removed]
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Document Date: 2014-04-10 10:15:52

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File Size: 163,38 KB

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City

Mabou Nova Scotia / /

Company

Model-Based RSA Software / based RSA / RSA Software LLZ System / Biomedical Inc. / In Vitro Diagnostics / Kl33966 Trade / based RSA Software / Halifax Biomedical Inc. / /

Country

Canada / /

Event

FDA Phase / /

Facility

Ravello Court / /

/

IndustryTerm

digital image post-processing / metal / image processing labs / medical imaging network / communications system / Internet address http /

OperatingSystem

Microsoft Windows / /

Organization

Radiological Health Office / NAPLES FL / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Bank of England / CDRH's office of Surveillance / /

Person

Daniel Kamm / Chad Munro / Janine M. Morr / Substantial Equivalence Chart / /

/

Position

Director / Division / Orthopedic specialist / CEO President / Principal Engineer / Model / /

Product

Federal Food / /

ProgrammingLanguage

FL / /

ProvinceOrState

Hawaii / /

Technology

radiation / BMP / operating system / Image Processing / medical imaging / /

URL

www.fda.Gov/MedicaiDevices/ResouircesforYou/lndustrv/default.htm / www.fda.oqov/Medicalflevices/Safetv / http /

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