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CUBEscan BioCon-1100A

by Mcube Technology Co., Ltd

CUBEscan BioCon-1100A is a Class II device made by Mcube Technology Co., Ltd, cleared under FDA 510(k) K201995 on 19 Aug 2020 and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 08809458500160), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K201995

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809458500160 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK201995 Date19 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201995 decided 19 Aug 2020 Active
  • FDA GUDID UDI-DI 08809458500160 listed 27 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201995
  2. Listed FDA GUDID 08809458500160

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CUBEscan
Generic name
Bladder volume ultrasound imaging system
Model / reference
BioCon-1100A
Primary DI / UDI-DI
08809458500160
510(k) Number
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
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K201995)

Similar devices

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Other devices from Mcube Technology Co., Ltd

See all devices from Mcube Technology Co., Ltd →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)