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510(k) Data Aggregation
K Number
K190769Device Name
Bladder Scanner (Models: M2, M2-W, M1, M1-W)
Manufacturer
Date Cleared
2019-05-22
(57 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Lischka Medtech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bladder Scanner (Models: M2, M2-W, M1, M1-W) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M2, M2-W, M1, M1-W Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M2, M2-W, M1, M1-W Bladder Scanner is intended to be used only by qualified medical professionals.
Device Description
The M Series Bladder Scanner manufactured by Suzhou Lischka Medtech Co., Ltd. provides noninvasive volume bladder measurement utilizing real-time ultrasound imaging and measurement. The equipment consists of the main unit, 3D probe (M2, M2-W)/2D probe (M1, M1-W), battery and Charger. It features:
- Two Operation Modes: Expert Mode and Easy Mode .
- Non-invasive, comfortable, correct, reliable, fast and simple operation .
- Printouts with ultrasound images and various parameters through PC software .
- . Touch screen keyboard operation
- . Voice input and play functions
- Multi-language selection .
- Information storage •
- . Information printing
- . built-in battery
The difference between these models is that the model of the probe is different. M2, M2-W is 3D probe .M1,M1-W is 2D probe. M2-W, M1-W have WIFI connection function, M2, M1 do not have WIFI connection function.
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