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Radiobiology / Radioactivity / Radiation therapy / Isocenter / Radiation treatment planning / Medical device / Prostate cancer / Ionizing radiation / Image-guided radiation therapy / Medicine / Radiation oncology / Medical physics


DEC[removed]K123137: 510(K) SUMMARY This 5 10(k) Summary is provided in accordance with 21 CER[removed]Date of preparation:
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Document Date: 2013-01-09 11:27:39


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File Size: 184,72 KB

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City

SEATTLE / /

Company

Radiological Health Center for Devices / K123137 Trade / Vf / In Vitro Diagnostics / EMC / Regulatory Affairs Varian Medical Systems / Varian Medical Systems / Siemens / /

Event

FDA Phase / /

Facility

Implanted Beacon / Surface Beacon / /

/

IndustryTerm

radiation therapy treatment systems / radiation thierapy treatment systems / announcements concerning your device / manufacturing practice requirements / radiation therapy systems / manufacturing practice / marketed predicate device / electromagnetic and optical technology / /

MedicalTreatment

radiation therapy / radiotherapy / radiation / /

Organization

Radiological Health Office / Division of Postmarket Surveillance / Food and Drug Administration / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use K123137 / Janine M. Morris Director Division / New Hampshire Avenue Document Contro Center / office of Surveillance / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /

Person

Silver Spring / Janine M. Morris / Marcia A Page / Marcia Page / /

/

Position

Director Quality Assurance / Director Quality Assurance and Regulatory Affairs Device trade name / /

Product

Food / /

ProgrammingLanguage

D / /

ProvinceOrState

Maryland / Washington / /

Technology

radiation / software Electromagnetic technology / http / electromagnetic and optical technology / /

URL

www.fda.gov/cdrh/industry/supportindex.htnl / www.fda.2 / /

SocialTag