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Ribbon symbolism / Medical ultrasound / Breast cancer / Medical physics / Mammography / Breast cancer screening / Risk factors for breast cancer / Ultrasound / Medical ultrasonography / Medicine / Oncology / Cancer screening


Microsoft Word - P110006 Final Proposed Summary of Safety and Effectiveness.docx
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City

Indio Way Sunnyvale / Pleasanton / Chicago / Sunnyvale / /

Company

TUV Rheinland of North America Inc. / New England Journal / Test Facility TUV Rheinland of North America Inc. / CA TUV Rheinland of North America Inc. / Effectiveness Data / Systems Inc. / /

Country

Taiwan / United States / Canada / /

Currency

pence / /

Event

FDA Phase / /

Facility

Automated Breast Scan Station / ABUS Scan Station / somo•VIEWer Work Station / /

IndustryTerm

automated algorithms / adaptive nipple shadow reduction tool / reverberation removal algorithm / software offers proprietary algorithms / adjunctive imaging methods / optimization algorithms / gain correction technologies / post‐processing algorithms / surface device / imaging / system software / /

MedicalCondition

breast cancers / symptomatic Cancer / Cancer / asymptomatic Non‐Cancer / Irritation / breast cancer / /

MedicalTreatment

clinical protocol / /

Organization

FDA / European Union / /

Person

NEMA UD / /

/

Position

General Information 4 A. Device / Executive / physician / General Information A. Device Generic Name Ultrasound Imaging Device / General / /

Product

CU72051803.01 / I110350 / P110006 / K052355 / /

ProvinceOrState

California / /

PublishedMedium

New England Journal of Medicine / /

Technology

cancer detection / gain correction technologies / post‐processing algorithms / ABUS technology / optimization algorithms / Ultrasound / Ultrasound System / reverberation removal algorithm / Medical Diagnostic / /

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