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510(k) Data Aggregation
K Number
K211665Device Name
SONON Ultrasound Imaging System, Model: SONON300C
Manufacturer
HEALCERION CO., LTD.
Date Cleared
2022-05-16
(349 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
HEALCERION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The system operating modes is B (Brightness), CF (color flow), PW (pulsed wave), M (motion). The intended to be used in a hospital or medical clinic is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility.
Device Description
The SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android, or PC that uses Windows operating system. The SONON Ultrasound Imaging System is a portable, general-purpose, softwarecontrolled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS or Android mobile device, or Windows PC, (ii) the SONON Ultrasound Imaging System software that runs as an app on the mobile device, (iii) the battery-operated, hand-held SONON Ultrasound Imaging System transducer that communicates wirelessly with iOS or Android mobile devices, and (iv) the instructions for use manual, battery, charger, and power cords. The SONON software can be downloaded to an iOS, Android mobile device or Windows PC and utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, controls for time gain, dynamic range, display of mirror image, focal length, depth, brightness, contrast, linear/elliptical measurement, color flow, and image annotation, as well as storage and PACS transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images on the screen in a B-Mode and Color Flow Doppler (CF Mode) Mode with 2-dimensional scan format. In addition, PW (pulsed wave) mode displays different wave velocities and directions in a spectrum. Moreover, in M mode (also known as "motion mode"), the changes over time on a line graph appears in a spectrum. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered. The SONON Ultrasound Imaging System utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen. The device components are not supplied sterile and do not require sterilization prior to use.
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K Number
K151339Device Name
SONON Ultrasound Imaging System (Model: SONON 300C)
Manufacturer
HEALCERION CO., LTD.
Date Cleared
2015-09-10
(114 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
HEALCERION CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
Device Description
The SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android operating system.
The SONON Ultrasound Imaging System is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS or Android mobile device. (ii) the SONON Ultrasound Imaging System software that runs as an app on the mobile device, (iii) the battery-operated, hand-held SONON Ultrasound Imaging System transducer that communicates wirelessly with iOS or Android mobile devices, and (iv) the instructions for use manual, battery, charger, and power cords.
The SONON software can be downloaded to an iOS or Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image capture and review. controls for time gain, dynamic range, display of mirror image, focal length, brightness, contrast, linear/elliptical measurement, and image annotation, as well as storage and email transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images on the screen in a B-Mode. 2dimensional scan format. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered.
The SONON Ultrasound Imaging System utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
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