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510(k) Data Aggregation
K Number
K183041Device Name
Full Digital Colour Doppler Ultrasonic Diagnostic System
Manufacturer
Date Cleared
2019-07-10
(251 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Zoncare Bio-medical Electronics Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:
Abdominal Gynecology(including endovaginal) Obstetric Cardiac Small parts(Breast,Testes,Thyroid,etc.) Urology Musculoskeletal Peripheral vascular
Device Description
The ZONCARE-M5 Ultrasound system consists of a main system along with associated transducers.
The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The ZONCARE-M5 system then analyzes the returned signal to generate an image or conduct Doppler processing.
The ZONCARE-M5 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.
The system provides hardware buttons for the User Interface.
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