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510(k) Data Aggregation

    K Number
    K142982
    Device Name
    OPUS 5100 Diagnostic Doppler Ultrasound System
    Date Cleared
    2015-09-03

    (323 days)

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

    Chang Gung Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OPUS 5100 Diagnostic Doppler Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdomen; Pediatric; Small Organ(breast, thyroid, tests); Cephalic (adult and neonatal); Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional and Superficial); Ob/GYN; Urology; Cardiac (adult and pediatric) and Peripheral Vascular.
    Device Description
    OPUS 5100 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 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 cost-effective system integration to a variety of upgrade-able options and features. The major features include: 128 Channel all digital beam former; progressive dynamic receive focusing; wide band all digital demodulation; native frequency digital scan converter; hand carried for portable use; remote access image management through LAN port: USB 2.0 drive for image storage and retrieving; Supports 2D Bmode (including Tissue Harmonic image, M-mode, TDI, Color Flow Doppler, Power Doppler, Pulse wave Doppler and Continuous Wave Doppler, or a combination of these modes, 3D/4D.
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    K Number
    K142751
    Device Name
    Chang Gung ComMed Series Dental Implant System
    Date Cleared
    2015-06-15

    (264 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chang Gung Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "ComMed" Series Dental Implant System is intended for surgical placement in the maxilla or mandible to provide for prosthetic attachment to restore a patient's chewing function. "ComMed" Series Dental Implants are intended only for delayed loading.
    Device Description
    The Chang Gung "ComMed" Series Dental Implant System includes threaded root-form endosseous dental implants (fixtures) and dental implant abutments (healing abutment, standard abutment, angle abutment). The implants are cylindrical and tapered posts made of Grade 4 Pure Titanium. The abutments are made of Ti6Al4V. The system features an internal hex with Morse Taper 8° connection, platform switching, and fine thread in the neck. Various diameters (3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm) and lengths (10, 11, 12, 13, 14, 15, 16 mm) are available for the implants. The surface treatment is blasted with Aluminum Oxide and Acid Etched, and it is also anodized. Implants are sterilized by Gamma irradiation, and abutments are sterilized by moist heat sterilization before use by clinicians.
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    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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