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510(k) Data Aggregation
K Number
K141720Device Name
iuStar300 Medical Ultrasound Diagnostic System
Manufacturer
Date Cleared
2015-07-23
(393 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
UNITED IMAGING SYSTEMS (BEIJING) CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.
Device Description
The iuStar300 Medical Ultrasound Diagnostic System is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs and for medical diagnostic purposes only. It supports 2D, M Mode, CFM and Pulse and Continuous Wave Spectral Doppler, Color Doppler Energy and Directional Color Doppler Energy modes.
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