# K091518: Cubescan Biocon-500 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Mcube Technology Co., Ltd.
- Decided: Jun 18, 2009 after 27 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: 4 generations back to K915436 (1992). 7 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 1.
- K053325: Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only); Multiscan Ultrasound System, Model M0001, Mediwatch, Ltd. (2005) Summary page 1.
- (no number) Model M0001/M0002: named in the summary without a submission number

## Most influential descendants
- K111021: Cubescan / Biocon-700 (2011), 13 descendants of its own
- K131227: Padscan HD Series Bladder Scanner (2013), 7 descendants of its own
- K171591: CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (2017), 4 descendants of its own
- K190769: Bladder Scanner (Models: M2, M2-W, M1, M1-W) (2019), 3 descendants of its own
- K201316: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (2021), 2 descendants of its own

## Indications for use
The BioCon-500 is a B-mode pulsed-echo ultrasound device. The BioCon-500 is intended to project ultrasound energy through the abdomen of the patient to obtain images of the bladder and to calculate the bladder volume non-invasively using these images. Contraindications for the BioCon-500 are fetal use and use on pregnant patients.

Source page: https://510kreport.com/device/K091518
Methodology: https://510kreport.com/methodology