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Neuroimaging / Radiobiology / Nuclear medicine / Single-photon emission computed tomography / Gated SPECT / Perfusion scanning / Gamma camera / Emission computed tomography / X-ray computed tomography / Medicine / Medical physics / Medical imaging


Z KI SFIE:CTIFvUL1301 -vtml
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Document Date: 2011-08-29 00:30:02

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File Size: 186,30 KB

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Company

ADAC Laboratories / K 110507 Trade / Spectrum Dynamics (Israel) Ltd. / Sc.D. / Cardiac SPECT / Submitter Information Spectrum Dynamics (Israel) Ltd. / /

Country

Israel / /

Event

FDA Phase / /

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IndustryTerm

communications system / external processing / announcements concerning your device / predicate devices / energy range / above mentioned predicate devices / manufacturing practice requirements / myocardial perfusion imaging / marketed predicate devices / detector technology / manufacturing practice / display equipment / marked devices / Internet address http /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / office of Device Evaluation / office of Surveillance / Devices Office / In Vitro Diagnostic Device Evaluation and Safety Center / DEPARTMENT OF HEALTH / Radiological Devices Office / /

Person

Silver Spring / Ilan Sharon / Mary S. Pastel / /

/

Position

detector head / closed detector head / Regulatory Affairs Consultant / chair / RA Consultant / Director Division / /

Product

Federal Food / /

ProvinceOrState

Maryland / /

Technology

DICOM protocol / tomography / Tomography System / detector technology / Quality of Service / ADO / /

URL

http /

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