# Mcube Technology Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 6 (2009–2020): 6 510(k) clearances
- Product codes: IYO (5), ITX (1)
- 510(k) review time since 2016: median 27 days, against 57 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 8 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Verathon Incorporated: 2 (https://510kreport.com/company/verathon)
- Mediwatch, Ltd.: 1 (https://510kreport.com/company/mediwatch)

## Firms that cite its devices most
- MEDA Co., Ltd.: 2 (https://510kreport.com/company/meda)
- Carenoso Technology Co., Ltd.: 1 (https://510kreport.com/company/carenoso-technology)

## Its most-cited devices
- K091518: Cubescan Biocon-500 Diagnostic Ultrasound System (2009), cited by 2
- K200548: CUBEScan BioCon-1100 (2020), cited by 2
- K171591: CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (2017), cited by 2
- K111021: Cubescan / Biocon-700 (2011), cited by 2

## Recent decisions
- K201995: CUBEScan BioCon-1100 (Aug 19, 2020)
- K200749: CUBEScan BioCon-900S (May 19, 2020)
- K200548: CUBEScan BioCon-1100 (Mar 27, 2020)
- K171591: CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (Jun 22, 2017)
- K111021: Cubescan / Biocon-700 (Apr 27, 2011)
- K091518: Cubescan Biocon-500 Diagnostic Ultrasound System (Jun 18, 2009)

Source page: https://510kreport.com/company/mcube-technology