Device
CUBEScan BioCon-1100A (Bladder volume measurement system) is a safe, easy to use, non-invasive system for measuring bladder volume (residual volume). CUBEScan BioCon-1100A is a B-m...
Manufacturer
Mcube Technology Co.,Ltd
Mcube Technology Co.,Ltd
Model: BioCon-1100A
DI: 08809458500160
Status: Update
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-28
Description
CUBEScan BioCon-1100A (Bladder volume measurement system) is a safe, easy to use, non-invasive system for measuring bladder volume (residual volume). CUBEScan BioCon-1100A 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-1100A. CubePro-1100A has functions such as printing measurement results, storing data and so on.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
ee38b630-929c-4640-bbb1-39004afe0061
Distribution Status:
In Commercial Distribution
DUNS Number:
689866580
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08809458500160
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41501
Name: Bladder volume ultrasound imaging system
Definition:
An assembly of portable, battery-powered devices designed for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It typically consists of an electronic measuring and imaging display unit with a connected ultrasound transducer which together reproduce digitized data of the bladder, typically bladder volume and post-void residual (PVR), and images. It will generate ultrasound pulses, direct them to a the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic three-dimensional (3-D) data/images. It is used in the diagnosis of urinary retention and postoperative urinary retention (POUR).
FDA Product Codes
IYO
System, Imaging, Pulsed Echo, Ultrasonic
ITX
Transducer, Ultrasonic, Diagnostic
Premarket Submissions
Submission Number:
K201995
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
40
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
75
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
70
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
106
Item #3 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #4 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling Low - @attributes - Value:
0
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling High - @attributes - Value:
55
Item #4 - Storage Handling Type:
Storage Environment Temperature
Item #5 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling Low - @attributes - Value:
20
Item #5 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling High - @attributes - Value:
80
Item #5 - Storage Handling Type:
Storage Environment Humidity
Item #6 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling Low - @attributes - Value:
60
Item #6 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling High - @attributes - Value:
106
Item #6 - Storage Handling Type:
Storage Environment Atmospheric Pressure