CUBEscan

GUDID 08809458500115

CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, non-invasive system for measuring bladder volume (residual volume). CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3D-mechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100. CubePro-1100 has functions such as printing measurement results, storing data and so on.

Mcube Technology Co., Ltd.

Bladder volume ultrasound imaging system
Primary Device ID08809458500115
NIH Device Record Keyf2d4ed35-65bf-406a-a84d-f9dda2aace5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUBEscan
Version Model NumberBioCon-1100
Company DUNS689866580
Company NameMcube Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 60 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108809458500115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-17
Device Publish Date2020-04-09

Trademark Results [CUBEscan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CUBESCAN
CUBESCAN
79060193 3655000 Live/Registered
Mcubetechnology Co., Ltd.
2008-06-05

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