CUBEscan

The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed…

Registry build 21.09.26

The BioCon-700 is a portable ultrasound system for measuring the urine volume in a patient. BioCon-700 transmits ultrasound signals to the abdomen of a patient and receives the echoed signals. Using the echoed signals the system detects the bladder outlines and calculates the volume in bladder outlines. BioCon-700 has a Pre-Scan function, which shows the ultrasound images for a horizontal plane consisted of the echoed signals. The Pre-Scan function helps a user locate the bladder easily and get more accurate results. A user can print the results using a built-in thermal printer after measurements right away. Also using the optional CubeScanPC software you can upload the saved data in a device’s flash ROM to a computer for reviewing the scan results.

44manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITX
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Ming FAI Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Xuzhou Yongkang Electronic Science Technology Co., Ltd. Xuzhou Jiangsu Contract manufacturer 13
Hony Medical Co., Ltd. Taishan Guangdong Contract manufacturer 10
Xian Friendship Medical Electronics Co., Ltd. Xi’An Shaanxi Contract manufacturer 10
Taijia Medical Electronics (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Chison Medical Technologies Co., Ltd. Wuxi Jiangsu Contract manufacturer 5
Philips Ultrasound (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 5
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56

Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic

Record

Regulatory record for CUBEscan
Listed by Mcube Technology Co., Ltd., South Korea
FDA product code ITX
Device type Transducer, Ultrasonic, Diagnostic
Device class Class 2
Regulation 21 CFR 892.1570
Establishment Manufacturer
Record published 2015-04-23
Record revised 2026-05-28 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Storage Storage environment atmospheric pressure 60 to 106 KiloPascal; Storage environment humidity 20 to 80 % RH; Storage environment temperature -10 to 60 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 40 °C

Catalogue Numbers

Catalogue numbers for CUBEscan
Catalogue number Size Status
BioCon-700 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
SonoScape Sonoscape Medical Corp. 302
Biopsy Starter Kit Civco Medical Instruments Co., Inc. 172
Sheathes Sheathing Technologies, Inc. 170
Needle Guide Civco Medical Instruments Co., Inc. 156
Sheathes3D Sheathing Technologies, Inc. 78
Ultrasound Probe Cover Biopsy Needle Guide Advance Medical Designs, Inc. 78
ultrasonic transducer Edan Instruments, Inc. 70
Unbranded Advance Medical Designs, Inc. 68
Reusable Biopsy Bracket Protek Medical Products, Inc. 60
Ultrasound Probe Cover Biopsy Needle Guide Kit Advance Medical Designs, Inc. 58
Biopsy Bracket Civco Medical Instruments Co., Inc. 56
Transducer Cover Civco Medical Instruments Co., Inc. 54

Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K111021 2011-04-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer