CUBEscan

Primary DI
08809458500009
Brand
CUBEscan
Company
Mcube Technology Co.,Ltd
Model
BioCon-900
Device description
CUBEScan BioCon-900 (bladder volume measurement system) is a safe and easy, noninvasive system to measure the bladder volume. CUBEScan BioCon-900 is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechnical sector transducer provides cross-sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen. Furthermore,a live image of the bladder during Pre-scan makes it easier to detect the bladder before scanning. Measurements are transmitted to a personal computer running CubePro software via a wireless connection. CubePro allows the user to input the patient information, print measurements, export to pdf or jpg, archive data, and review data.
Published
2017-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171591000CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd.2017-06-22IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809458500009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809458500009088094585000098809458500009

GMDN Terms#

Term, Definition table
TermDefinition
Bladder volume ultrasound imaging systemAn 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure60 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
689866580
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809458500016CUBEscanBioCon-7002015-04-23
08809458500023CUBEscanBioCon-5002015-04-24
08809458500085CUBEscanBioCon-900S2020-06-05
08809458500108CUBEscanBioCon-7502016-11-28
08809458500160CUBEscanBioCon-1100A2026-04-27
08809458500115CUBEscanBioCon-11002020-04-09

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