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Radiobiology / Neurosurgery / Medical technology / Radiosurgery / Cyberknife / Stereotactic surgery / Radiation therapy / Glioma / Meningioma / Medicine / Radiation oncology / Brain tumor


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service __________________________________________________________________________________________________________________________ Food and Drug Administration[removed]N
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Document Date: 2014-10-06 09:56:10

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City

Palo Alto / /

Company

Varian Medical Systems Inc. / Radiotherapy Delivery Systems / CyberKnife VSI Systems / In Vitro Diagnostics / Summary TrueBeam/Edge Radiotherapy Delivery Systems / K140528 Trade / Systems Inc. / /

Country

United States / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

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IndustryTerm

predicate device / manufacturing practice requirements / manufacturing practice / Internet address http /

MedicalCondition

skull base tumors / meningioma / pediatric tumors / spine tumors / metastasis / glioma / non-Hodgkin’s lymphoma / arteriovenous malformation / hemangioblastoma / thymic tumors / gynecologic tumors / melanoma / craniopharyngioma / pituitary tumors / medulloblastoma / nasopharyngeal tumors / mesothelioma / hemangioblastoma / orbital tumors / nonHodgkin’s lymphoma / spinal cord tumors / anal carcinoma / trigeminal neuralgia / chordoma / esophageal cancer / ocular tumors / head tumors / craniopharyngioma / neck tumors / brain tumors / ependymoma / pituitary tumors / tumors / benign diseases / gastrointestinal tumors / breast tumors / lung cancer / lymphoid tumors / hemangiomas / diseases / sarcomas / thoracic tumors / skin cancers / optic nerve tumors / thyroid cancer / schwannoma / arteriovenous malformation / genitourinary tumors / /

MedicalTreatment

radiation therapy / stereotactic radiosurgery / radiotherapy / radiation / /

Organization

Radiological Health Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / For Janine M. Morris Director Division / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH’s office of Surveillance / HUMAN SERVICES Public Health Service / Center for Devices and Radiological Health / Radiological Health Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / /

Person

Silver Spring / Peter J. Coronado / Janine M. Morris / /

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Position

Director / Global Regulatory Affairs / /

Product

Federal Food / /

ProvinceOrState

Maryland / California / /

Technology

radiation / X-ray / /

URL

http /

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