# K201316: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Peaksonic Medical Technology Co., Ltd.
- Decided: Feb 26, 2021 after 284 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: 8 generations back to K915436 (1992). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190769: Bladder Scanner (Models: M2, M2-W, M1, M1-W), Suzhou Lischka Medtech Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K250331: Astrasono A3Pro Bladder Scanner (A3Pro) (2025), 0 descendants of its own
- K230986: Bladder Scanner (2023), 0 descendants of its own

## Indications for use
The Bladder Scanner (Models: M3, M3-HD, M4, M4-HD) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M3, M3-HD, M4, M4-HD 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 M3, M3-HD, M4, M4-HD Bladder Scanner is intended to be used only by qualified medical professionals.

Source page: https://510kreport.com/device/K201316
Methodology: https://510kreport.com/methodology