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510(k) Data Aggregation
K Number
K233579Device Name
SC1 Handheld Ultrasound Imaging system (Model: SC1)
Manufacturer
FCU Co., Ltd.
Date Cleared
2024-06-26
(232 days)
Product Code
IYO, ITX, IYN
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
FCU Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode. Flow detection is possible using PWD (Power Doppler) mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Device Description
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (Power Doppler); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (iii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement.
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode and PD-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) provides functions on patient data (entering new patient information, editing patient data saving, storing, or transferring patient information). It is possible to connect to the PACS DICOM network (hospital network) to get the list of exams and export recorded exams. However, there is no option to export patient data via a USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
SC1 Handheld 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
K210468Device Name
SC1 Handheld Ultrasound Imaging System (Model: SC1)
Manufacturer
FCU Co., Ltd.
Date Cleared
2021-07-23
(157 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
FCU Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SC1 Handheld Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.
Device Description
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (2D); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (ii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement.
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) is not intended to provide any function on patient data (entering new patient information, editing patient data saving, or transferring or exporting patient information). It does not have capability to connect to the PACS or equivalent DICOM network or export any patient data via USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
The SC1 Handheld 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.
Ask a Question
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