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510(k) Data Aggregation
K Number
K170046Device Name
Lilium a-200E
Manufacturer
Date Cleared
2017-12-07
(336 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Lilium Otsuka Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Lilium α-200E, using ultrasound, is intended to provide the diagnostic information of the visualized urine dynamics acquired from the volume of the urinary bladder.
Device Description
Lilium α-200E is a portable, battery powered, software controlled ultrasound system used to acquire and display real time A-mode images of the bladder. The Lilium device consists of a main body and an ultrasonic probe. Lilium device is used to measure urine volume inside the bladder non-invasively. In addition, it provides urine volume in the bladder at regular intervals and graphically displays the gradual increase of urine collection. It alerts when a set volume is attained. The device retains history. This information aids healthcare professionals, patients, and caregivers in providing proper continence care for those with urination difficulties. The device has wireless capabilities.
The Lilium device measures urine volume by means of a probe that has four ultrasound sensors aligned vertically. The sensor aligned side is applied to outside the abdomen wall so the probe can emit ultrasound (Mode A) toward the bladder and receive the echoed signals. The device the signal intensity to measure the height and depth of the bladder. These measurements determine the size of the bladder and quantify the filling of the bladder (urine volume is displayed on the screen. The system also includes indicator lights to indicate for urine volume and for correct positioning of the device.
The operating principle of the device is as follows:
An ultrasonic probe in which ultrasound transducers are arranged is placed on the abdominal surface, above the pubic bone, along the extending direction of the urinary bladder. When the ultrasound is transmitted from the probe, transducers put on the base part of the bladder detect echoes or ultrasonic reflections first when the urine begins to accumulate. As the bladder volume increases, transducers on the upper bladder detect echoes.
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