Terason

The Terason uSmart3200T MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound…

Registry build 21.09.26

The Terason uSmart3200T MUX is an electronic device intended to be used with an ultrasound (US) imaging system to enable the simultaneous connection of multiple hand-held ultrasound transducers so the user can conveniently switch between transducers as required. The unit with multiple transducer ports and is attached to the Terason uSmart3200T Cart.

44manufacturers in China registered for this device type
13catalogue numbers in this listing
4510(k) clearances naming this product code

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 Terason
Listed by Teratech Corp., United States
FDA product code ITX
Device type Transducer, Ultrasonic, Diagnostic
Device class Class 2
Regulation 21 CFR 892.1570
Establishment Manufacturer
Record published 2018-04-06
Record revised 2022-11-28 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Terason
Catalogue number Size Status
8L2 In distribution
15L4A In distribution
16HL7 In distribution
8V3A In distribution
uSmart3200T MUX In distribution
4V2A In distribution
PDOF In distribution
5C2A In distribution
8EC4A In distribution
9MC3 In distribution
12L5A In distribution
8BP4 In distribution
15L4 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
K110020 2011-01-20
K043278 2004-12-13
K040840 2004-04-14
K010883 2001-04-06

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