X-Cube 70

The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue…

Registry build 21.09.26

The X-CUBE 70 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode. The X-CUBE 70 is intended to be used in a hospital or medical clinic.

44manufacturers in China registered for this device type
1catalogue number

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 X-Cube 70
Listed by Alpinion Medical Systems Co., Ltd., South Korea
FDA product code ITX
Device type Transducer, Ultrasonic, Diagnostic
Device class Class 2
Regulation 21 CFR 892.1570
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Record published 2020-07-15
Record revised 2024-11-18 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for X-Cube 70
Catalogue number Size Status
X-CUBE 70 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

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