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510(k) Data Aggregation
K Number
K221568Device Name
KOLO Evolution XHD Series Ultrasound Diagnostic System
Manufacturer
Date Cleared
2022-09-12
(104 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Kolo Medical (Suzhou) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Evolution XHD Series Ultrasound Diagnostic System is a high frequency general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The Evolution XHD Series Diagnostic Ultrasound System is applicable for adult and pediatric. It is intended for use in Pediatric, Small parts (breast, thyroid, testicles, prostate), Peripheral vessel, Dermatological, Musculoskeletal (conventional), Musculoskeletal (superficial).
Modes of operation include: B Mode, Color Doppler, Power Doppler, Combined modes: B+Color Doppler, B+Power Doppler, B+PW Doppler.
Device Description
The Evolution XHD Series device is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire and display high-resolution, real-time ultrasound data. The Evolution XHD Series device is comprised of transducers responsible for ultrasound signal generation, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
The main unit is a laptop ultrasound console with integrated keyboard, a color video LCD type display and operates from an integrated battery or separate power supply/charger.
Evolution XHD Ultrasound Diagnostic System integrated 4 linear probe transducers: L22-8 K2, L28-12K2, L38-22K2, L62-38K2.
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