# K171591: CUBEScan™ BioCon-900 (Bladder Volume Measurement System)

- Pathway: 510(k) (Traditional)
- Applicant: Mcube Technology Co., Ltd.
- Decided: Jun 22, 2017 after 22 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: 6 generations back to K915436 (1992). 9 ancestors in all.
4 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)
- K111021: Cubescan / Biocon-700, Mcube Technology Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K200548: CUBEScan BioCon-1100 (2020), 2 descendants of its own
- K260313: MD-6000S Bladder Scanner (2026), 0 descendants of its own
- K201995: CUBEScan BioCon-1100 (2020), 0 descendants of its own
- K200749: CUBEScan BioCon-900S (2020), 0 descendants of its own

## Indications for use
BioCon-900 is a B-mode pulsed-echo ultrasound device. The BioCon-900 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. BioCon-900 is intended to be used by a qualified medical professional to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-900 are fetal use and use on pregnant patients.

Source page: https://510kreport.com/device/K171591
Methodology: https://510kreport.com/methodology