Search Results

The Bladder Scanner is B-mode pulsed-echo ultrasound device adopts a 3D mechanical fan scanning probe for the ultrasonic scanning for bladder and measures the bladder volume from the abdominal surface of ultrasonic imaging. The Bladder Scanner is intended to be used only in hospital and by qualified medical professionals.

The Bladder Scanner (Model: AS-2) is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging. The proposed device consists of the main unit (include 3D probe), battery power adapter and USB charging cable.

This FDA 510(k) summary provides information for a device called "Bladder Scanner" (Model: AS-2) by Avantsonic Technology Co., Ltd. The document primarily focuses on establishing substantial equivalence to a predicate device (K201316 Bladder Scanner by Suzhou Peaksonic Medical Technology Co., Ltd.) rather than detailing an independent study against acceptance criteria. However, it does state the acceptance criteria for volume measurement accuracy and reports whether the device met these criteria through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Ask a specific question about this device