CUBEscan

Primary DI
08809458500085
Brand
CUBEscan
Company
Mcube Technology Co.,Ltd
Model
BioCon-900S
Device description
CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe and various components. The probe is a B-mode instrument, which is hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides cross–sectional images of the bladder from up to 12 scan planes which users can check through the screen and bladder volume is calculated based upon those images. In addition, the Pre-scan function allows users to easily locate the bladder before scanning, making measurement easier. CUBEScan BioCon-900S consists of a probe and CUBEscan Charger or a probe and CUBEScan Docking Station, with an optional mobile cart and a barcode module.
Published
2020-06-05
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
K200749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200749000CUBEScan BioCon-900SMcube Technology Co., Ltd.2020-05-19IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809458500085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809458500085088094585000858809458500085

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
08809458500009CUBEscanBioCon-9002017-06-30
08809458500016CUBEscanBioCon-7002015-04-23
08809458500023CUBEscanBioCon-5002015-04-24
08809458500108CUBEscanBioCon-7502016-11-28
08809458500160CUBEscanBioCon-1100A2026-04-27
08809458500115CUBEscanBioCon-11002020-04-09

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