CUBEscan BioCon-750
CUBEscan BioCon-750 is a bladder volume ultrasound imaging system (FDA Class II) made by Mcube Technology Co., Ltd, listed in FDA GUDID since 28 Nov 2016 (UDI-DI 08809458500108), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08809458500108 | Date28 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 08809458500108
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- CUBEscan
- Generic name
- Bladder volume ultrasound imaging system
- Model / reference
- BioCon-750
- Primary DI / UDI-DI
- 08809458500108
- FDA product code
- IYO, ITX
- GMDN term
- Bladder volume ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1560, 892.1570
- GUDID distribution status
- In Commercial Distribution
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