# CUBEscan BioCon-1100A

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/cubescan-biocon-1100a>
- Manufacturer: [Mcube Technology Co., Ltd](https://devicerts.com/manufacturers/mcube-technology-co-ltd) (South Korea)
- Device class: Class II (US FDA)
- FDA product code: IYO, ITX
- GMDN: Bladder volume ultrasound imaging system (41501)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 08809458500160 · listed 2026-04-27 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K201995 · decision 2020-08-19 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: CUBEscan [FDA GUDID (AccessGUDID)]
- Generic name: Bladder volume ultrasound imaging system [FDA GUDID (AccessGUDID)]
- Model / reference: BioCon-1100A [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08809458500160 [FDA GUDID (AccessGUDID)]
- 510(k) Number: K201995 [FDA GUDID (AccessGUDID)]
- FDA product code: IYO [FDA GUDID (AccessGUDID)]; ITX [FDA GUDID (AccessGUDID)]
- GMDN term: Bladder volume ultrasound imaging system (41501) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.1560 [FDA GUDID (AccessGUDID)]; 892.1570 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: CUBEscan BioCon-1100A, Mcube Technology Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/cubescan-biocon-1100a (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/cubescan-biocon-1100a.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/cubescan-biocon-1100a
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.