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510(k) Data Aggregation
K Number
K231354Device Name
Pocket Ultrasound System (C10)
Manufacturer
Date Cleared
2023-12-20
(224 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Beijing Konted Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pocket Ultrasound System C10 is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes:
Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology
Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo.
The Pocket Ultrasound System C10 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Device Description
The Pocket Ultrasound System C10 is designed to be a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data through an off-the-shelf (OTS) Android device. the system mainly includes the ultrasound equipment and software application components. The ultrasound equipment is used to complete the ultrasonic imaging function and the software application components are used to complete the image display, measurement, patient information management as well as image storage etc. The Pocket Ultrasound System comprises a series of wireless transducers employing Wi-Fi-based technology to communicate with smartphone devices via direct Wi-Fi. One of the software application components is a software APP (MY USG), which is deployed on Android devices which supported Wi-Fi wireless communication. The other one is the software contained in the ultrasound equipment to control operation of the equipment and transfer images via Wi-Fi to the smartphone devices. This allows the user to export ultrasound images and display them across a range of portable personal devices. The communication protocol between the software APP and the other software contained in the equipment is specially defined for unique connection.
The system is only intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology. The Pocket Ultrasound System comprises the following:
• A commercial off-the-shelf (COTS) Android smartphone/tablet device.
· the software application (MY USG) running as an App on the COTS device with Android system.
• The ultrasound equipment/Transducers: C10
• Accessory: Wireless Battery Charger & Power Adapter
Different type transducers are available for the Pocket Ultrasound System C10, the frequencies are 2.5 MHz and 7.5MHz respectively depending on different transducer. The Pocket Ultrasound System C10 is designed with four ultrasound modes of operation, including B-mode, Combination Mode (B+M mode), Color Doppler mode and Pulsed Wave Doppler mode.
Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color Doppler mode and Pulsed Wave Doppler mode. Combination mode B+M-mode is the combination of the B-mode and M-mode of operation, superimposed on the display. Mmode is defined as time motion display of the ultrasound wave along a chosen ultrasound line, so it's usually applied in diagnosis of cardiovascular diseases.
The system provides real-time images for tissues, organs or blood flow via touch screen of the COTS Android smartphone/tablet device, which, in combination with the embedded software system contained in the ultrasound device, provides users a friendly and convenient graphical interface and makes users be able to easily control the whole system.
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