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Food and Drug Administration / Medical equipment / Radiobiology / Medical device / Radiation treatment planning / Radiation therapy / Federal Food / Drug / and Cosmetic Act / DICOM / Center for Devices and Radiological Health / Medicine / Radiation oncology / Medical physics


Document Date: 2012-05-28 00:34:49

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File Size: 177,52 KB

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City

Document / Stockholm / /

Company

RaySearch Laboratories AB / DRaySearch Laboratories AB / K120387 Trade / RayScarch Laboratories AB / /

Event

FDA Phase / /

/

IndustryTerm

software system / treatment energy / dose tracking technology / software platform / announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address hqp / /

MedicalTreatment

Radiation treatment / radiation therapy / /

Organization

Division Sign-Off Office / Division of Postmarket Surveillance / Food and Drug Administration / In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure Title / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Radiological Devices Office / /

Person

Silver Spring / David Hedfors / /

/

Position

cing Director Division / Manager RaySearch Laboratories ABAP Sveavagen / Regulatory Affairs Manager / Manager 5.3 Preparation date / IPLAN RT / predicate device IPLAN RT / /

Product

Federal Food / /

ProgrammingLanguage

ABAP / /

ProvinceOrState

Maryland / Connecticut / /

Technology

Radiation / 2.5 dose tracking technology / /

URL

http /

SocialTag