# K230986: Bladder Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Avantsonic Technology Co., Ltd.
- Decided: Dec 29, 2023 after 267 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: 9 generations back to K915436 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201316: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD), Suzhou Peaksonic Medical Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
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 utilizing the principles of ultrasonic imaging. The Bladder Scanner is intended to be used only in hospital and by qualified medical professionals.

Source page: https://510kreport.com/device/K230986
Methodology: https://510kreport.com/methodology