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FDA 510(k)

CUBEScan™ BioCon-900 (Bladder Volume Measurement System)

K-Number: K171591 · 2017-06-22

ApplicantMcube Technology Co., Ltd.
Decision Date2017-06-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CUBEScan™ BioCon-900 (Bladder Volume Measurement System) is a medical device manufactured by Mcube Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-06-22 under approval number K171591. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUBEScan™ BioCon-900 (Bladder Volume Measurement System)?

CUBEScan™ BioCon-900 (Bladder Volume Measurement System) is a medical device that received FDA 510(k) clearance on 2017-06-22. It is manufactured by Mcube Technology Co., Ltd.. The 510(k) number is K171591.

When was CUBEScan™ BioCon-900 (Bladder Volume Measurement System) approved by the FDA?

CUBEScan™ BioCon-900 (Bladder Volume Measurement System) received FDA 510(k) clearance on 2017-06-22, under approval number K171591.

What company makes CUBEScan™ BioCon-900 (Bladder Volume Measurement System)?

CUBEScan™ BioCon-900 (Bladder Volume Measurement System) is manufactured by Mcube Technology Co., Ltd..

What is the FDA product code for CUBEScan™ BioCon-900 (Bladder Volume Measurement System)?

The FDA product code for CUBEScan™ BioCon-900 (Bladder Volume Measurement System) is IYO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Mcube Technology Co., Ltd.

K201995CUBEScan BioCon-1100 K200749CUBEScan BioCon-900S K200548CUBEScan BioCon-1100

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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