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: The BioCon-750 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-750 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-750 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScan PC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results. FDA UDI
Model / Reference: BioCon-750 FDA UDI
Description: The BioCon-750 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-750 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-750 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScan PC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809458500108 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

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

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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 a5ed3d51-0613-40fb-b41c-2ce1d39ab11e 34 fields · synced May 30, 2026