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Medical device / Medical equipment / Medical technology / Angiography / Viatronix / Medicine / X-ray computed tomography / Cardiac imaging


i FUJIFILM Medical Systems U.S.A., Inc. Synapse 3D Cardiac Tools (V3.0) 510O(k[removed]k) Summary
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Document Date: 2012-08-06 18:53:25

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City

Stamford / /

Company

FUJIFIM Medical Systems U.S.A. Inc. / 3C FWIFILM Medical Systems U.S.A. Inc. / K120636 Trade / Synapse 3D Cardiac Tools / FWIFILM Medical Systems U.S.A. Inc. / FUJIFILM Medical Systems U.S.A. Inc. / /

Currency

pence / /

Event

FDA Phase / /

/

IndustryTerm

subject device / Internet address http /

MedicalCondition

stroke / /

MedicalTreatment

CPR / /

Organization

Division of Postmarket Surveillance / cgDirector Division / Food and Drug Administration / Center for Devices and Radiological Health / In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure Mj120656 Indications for Use / Divsio Sign-Page Division / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Radiological Devices Office / /

Person

Lin / SHYAN UIN / Synapse / /

/

Position

Manager / Regulatory / /

Product

K1 / /

ProvinceOrState

New Mexico / Maryland / Connecticut / /

Technology

design verification / clinically accepted calcium scoring algorithms / tomography / Image Processing / Medical Imaging / /

URL

http /

SocialTag