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510(k) Data Aggregation
K Number
K234153Device Name
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
Manufacturer
Date Cleared
2024-09-18
(264 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
EdgeLife Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable softwarecontrolled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes. The EdgeLife Handheld Wireless Ultrasound System is intended for diagnostic ultrasound echo imaging, measurement, and fluid flow analysis of the human body for the following clinical applications.
The specific clinical applications and exam types for the linear transducer include vascular, musculoskeletal (conventional and superficial), small organs, thoracic/lung, abdominal, intraoperative (excluding neurological, central nervous system, non-central cardiovascular system), urology, gynecology, pediatric, fetal, peripheral vessel, carotid, interventional and procedure guidance of needles into the body.
The specific clinical applications and exam types for the convex transducer include: abdominal, pulmonary, thoracic, intra-operative (abdominal organs & vascular), pediatric, small organ, urology, obstetrics, musculoskeletal (conventional and superficial), vascular, carotid, and cardiac (adult and pediatric).
The specific clinical applications and exam types for the Endocavitary transducer include gynecology, obstetrics, urology, transvaginal, transrectal, and interventional procedures.
The system is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
Device Description
The EdgeLife Handheld Wireless Ultrasound System is a general-purpose, handheld, wireless, portable software-controlled ultrasonic diagnostic system that uses pulsed-echo technology to acquire and display ultrasound data in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes.
The EdgeLife Ultrasound Scanner receives instructions from and transmits images to the EdgeLife Ultrasound App running on a paired mobile device that utilizes the iOS operating system via wireless Wi-Fi communication.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided.
The EdgeLife Handheld Wireless Ultrasound System consists of:
- EdgeLife Handheld Ultrasound Scanner:
- o Model E8200 with convex and linear transducers
- o Model E8220 with convex and endocavitary transducers
- EdgeLife Ultrasound App .
- Standard off-the-shelf Wireless Qi charger (not a medical device) ●
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