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510(k) Data Aggregation

    K Number
    K102989
    Device Name
    OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
    Date Cleared
    2010-12-09

    (64 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Orqan(breast.tests.thyroid);heart soft tissue; Peripheral Vascular; Musculo-skeletal(conventional); Ob/Gyn and Urology. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: General (TRACK 1 ONLY), Specific (TRACKS 1 & 3) Mode of Operation: B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Other* Combined, Tissue Harmonic Imaging Specific Applications: Ophthalmic, Fetal, Abdominal, Intra-operative Specify, Intra-operative Neuro, Laparoscopic, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph.(non-Card), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Other (Ob/GYN), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (specify), Peripheral vessel, Other (specify) Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
    Device Description
    The CGMC OPUS 5000 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device,have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows costeffective system integration to a variety of upgrade-able options and features. The major features of the CGMC OPUS 5000: - · 64 Channel all digital beam former - · Progressive dynamic receive focusing - · Wide band all digital demodulation - Native frequency digital scan converter - . OPUS 5000 can be hand carried for portable use - Remote access image management through LAN port - USB2.0 flash drive for image transport and software upgrade - Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, . Pulse wave Doppler, and CW.
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