Diagnostic Ultrasound System
9 catalogue numbers from CUS-X200G, listed by Canon Inc., Japan, under System, Imaging, Pulsed Echo, Ultrasonic. 37 manufacturers in China are registered for this product code.
37manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (9), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| 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 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Showing 12 of 37. All 37 manufacturers in China registered for System, Imaging, Pulsed Echo, Ultrasonic
Record
| Listed by | Canon Inc., Japan |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K182596 |
| Record published | 2019-02-13 |
| Record revised | 2026-05-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CUS-X200G | In distribution | |
| TUS-AI700 | In distribution | |
| TUS-AI900 | In distribution | |
| TUS-X100 | In distribution | |
| TUS-X100S | In distribution | |
| TUS-A400 | In distribution | |
| TUS-VC100 | In distribution | |
| TUS-X200 | In distribution | |
| TUS-AI800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hitachi | Hitachi, Ltd. | 224 |
| eTRAX™ Needle | Civco Medical Instruments Co., Inc. | 43 |
| BladderScan® | Verathon Inc. | 38 |
| Verza Guidance System | Civco Medical Instruments Co., Inc. | 37 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 34 |
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 34 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 33 |
| Tracking Bracket Starter Kit | Civco Medical Instruments Co., Inc. | 29 |
| System, Imaging, Pulsed Echo, Ultrasonic | GE Healthcare Japan Corporation | 23 |
| eTRAX™ Needle System Starter Kit | Civco Medical Instruments Co., Inc. | 20 |
| Tracking Bracket | Civco Medical Instruments Co., Inc. | 19 |
| Logiq | GE Ultrasound Korea, Ltd. | 18 |
Showing 12 of 805. All products under System, Imaging, Pulsed Echo, Ultrasonic
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Canon Medical System, USA, Inc. | UDI-DI | 2022-09-29 | Class II | Software Design Change | After completion, ultrasound system’s Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed “Same view was saved in this phase. Do you us | 65 | |
| Toshiba American Medical Systems Inc | 510(k) number | 2018-01-04 | Class II | Software design | The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON. | 162 units total | 2023-10-10 |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-05-01 | Class II | Software Manufacturing/Software Deployment | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below. | 7 units | 2023-10-11 |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-05-01 | Class II | Software Manufacturing/Software Deployment | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below. | 1 unit | 2023-10-11 |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-05-01 | Class II | Software Manufacturing/Software Deployment | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below. | 90 units | 2023-10-11 |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-05-01 | Class II | Software Manufacturing/Software Deployment | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below. | 307 units | 2023-10-11 |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-05-01 | Class II | Software Manufacturing/Software Deployment | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below. | 28 units | 2023-10-11 |
| Toshiba American Medical Systems Inc | 510(k) number | 2016-08-04 | Class II | Software design | Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error. | 93 units | 2017-11-17 |
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.