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510(k) Data Aggregation
K Number
K231889Device Name
Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
Manufacturer
Date Cleared
2023-12-21
(177 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Ultrasound Biotechnology (Shanghai) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Endoscopic Ultrasonic Diagnostic Equipment/Disposable Sterile Ultrasonic Probe is intended to be used in conjunction with ultrasound endoscopes to acquire and display real-time ultrasound images of the target organs. This device is indicated for intraluminal ultrasound imaging of the upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs.
Mode of operation includes B mode. This device is intended for use by a qualified and trained healthcare professional in a hospital setting or medical clinic.
Device Description
Endoscopic Ultrasonic Diagnostic Equipment consist of main unit, control panel, driver box, trolley, and display,it is used in conjunction with Disposable Sterile Endoscopic Ultrasonic Probe to acquire and display high-resolution and high-penetration.real-time ultrasound images of the target organs. Disposable Sterile Endoscopic Ultrasonic Probe is single-use.
The subject system only has B mode.
The subject system provide measurements and calculations of distance,area,circumference, it also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external recording device.
The subject system will be used with compatible endoscope system : Bronchoscope System (EOS-H-01, Shanghai AnQin Medical Instrument Co.Ltd)cleared under K211169.
-working length maximum 600mm
-Insrument channel dimaeter minimum 1.7mm
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