CUBEscan

FDA UDI

Class II (US FDA UDI)

by Mcube Technology Co., Ltd.

Identity

Trade Name: CUBEscan FDA UDI
Generic Name: Bladder volume ultrasound imaging system FDA UDI
Device Name: CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, non-invasive system for measuring bladder volume (residual volume). CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3D-mechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100. CubePro-1100 has functions such as printing measurement results, storing data and so on. FDA UDI
Model / Reference: BioCon-1100 FDA UDI
Description: CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, non-invasive system for measuring bladder volume (residual volume). CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3D-mechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100. CubePro-1100 has functions such as printing measurement results, storing data and so on. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809458500115 FDA UDI
510(k) Number: K200548 FDA UDI
FDA Product Code: IYO FDA UDI
ITX FDA UDI
GMDN Term: Bladder volume ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
892.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bladder volume ultrasound imaging system

CUBEscan by Mcube Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bladder volume ultrasound imaging system.

BladderScan® — Verathon Inc. · Class II
BladderScan® — Verathon Inc. · Class II
Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
BBS Revolution™ — Dbmedx, Inc. · Class II
Caresono — Caresono Technology Co., Ltd. · Class II
AVANTSONIC — Avantsonic Technology Co., Ltd. · Class II
Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
ScanPoint® — Verathon Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mcube Technology Co., Ltd.

Sources (1)

FDA UDI f2d4ed35-65bf-406a-a84d-f9dda2aace5d 35 fields · synced May 30, 2026