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CUBEscan

Mcube Technology Co.,Ltd · Model BioCon-700 · UDI-DI 08809458500016

ITX IYO Prescription

510(k) clearances

3,948

Adverse events (23 deaths)

147

Recalls

396

Facilities

Description

The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 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-700 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 CubeScanPC software you can upload the saved data in a device's flash ROM to a computer for reviewing the scan results.

Recalls

Date	Firm	Reason
2025-11-17	Sheathing Technologies Inc	Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-09-05	Philips Ultrasound, Inc	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.