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Radiation therapy / External beam radiotherapy / Stereotactic surgery / Linear particle accelerator / Medicine / Radiation oncology / Radiosurgery


I W2[removed]k) Summary In Compliance with 21 CFR Section[removed]c) I.
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Document Date: 2013-09-13 12:40:32

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City

Crawley / Congers / No. / /

Company

Anzai Medical Company Ltd. / In Vitro Diagnostics / Elekta Limited / Aktina Medical Corporation / Elekia Limited / Kl131313 Trade / /

Country

Japan / United Kingdom / /

Event

FDA Phase / /

/

IndustryTerm

flow meter device / surface devices / Internet address Sincerely / announcements concerning your device / predicate devices / technology characteristics / predicate device / manufacturing practice requirements / personal computer software / marketed predicate devices / manufacturing practice / Internet address It / software specification testing / /

MedicalCondition

tumor / lymphoma / Pancreatic tumors / Breast tumors / Liver tumors / thoracie tumors / thoracic tumors / DISH / Lung cancers / /

MedicalTreatment

radiation therapy / Stereotactic Radiosurgery / Radiation / /

Organization

Radiological Health Office / Division of Small Manufacturers / Radiological Health Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Radiological HeIalth Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / NewvHampshire Avenue Docuntn Conrol Center / /

Person

Janine M. Morris / Tony Spaccarotella / /

/

Position

therapist / Active Breathing Coordinator / Director / Use The Active Breathing Coordinator / Director / QA/RA / K13l313 Active Breathing Coordinator / /

Product

Federal Food / K123808 / /

ProgrammingLanguage

ABC / /

ProvinceOrState

New York / /

Technology

radiation / same technology / simulation / /

SocialTag