# K153581: Bladder Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Caresono Technology Co., Ltd.
- Decided: Apr 8, 2016 after 115 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K915436 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131227: Padscan HD Series Bladder Scanner, Carenoso Technology Co., Ltd. (2013) Summary page 6.

## Indications for use
The Bladder Scanner(model: PadScan HD2) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The PadScan HD2 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 PadScan HD2 Bladder Scanner is intended to be used only by qualified medical professionals.

Source page: https://510kreport.com/device/K153581
Methodology: https://510kreport.com/methodology