Diagnostic Ultrasound System
9 catalogue numbers from CUS-AA450, listed by Canon Inc., Japan, under Transducer, Ultrasonic, Diagnostic. 44 manufacturers in China are registered for this product code.
44manufacturers in China registered for this device type
9catalogue numbers in this listing
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.
| 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
| Listed by | Canon Inc., Japan |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K182427 |
| Record published | 2019-02-04 |
| Record revised | 2026-03-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CUS-AA450 | In distribution | |
| TUS-A500 | In distribution | |
| CUS-X100G | In distribution | |
| CUS-AA550 | In distribution | |
| TUS-AI600 | In distribution | |
| SSH-880CV | In distribution | |
| SSA-640A | In distribution | |
| TUS-A300 | In distribution | |
| SSA-680A | In distribution |
Same 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
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Canon Medical System, USA, Inc. | 510(k) number | 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 | 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 | 2013-08-05 | Class II | Device Design | The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When | 477 (1352 total) | 2016-06-28 |
| Toshiba American Medical Systems Inc | 510(k) number | 2010-10-01 | Not classified | Software design | Toshiba America Medical Systems, Inc. is initiating a field correction on the Aplio Artida Ultrasound Diagnostic System because the panel operation for the Aplio Artida may become disabled (i.e., system may hang up) when processing to displ | 46 units | 2012-04-20 |
| Toshiba American Medical Systems Inc | 510(k) number | 2010-09-28 | Not classified | Software design | Toshiba America Medical Systems is initiating a field correction on the SSH-880CV Aplio Artida Diagnostic Ultrasound System due to software issues. | 40 units | 2012-05-02 |
| Toshiba American Medical Systems Inc | 510(k) number | 2010-04-20 | Not classified | Device Design | There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely. | 14 | 2011-05-25 |
| Toshiba American Medical Systems Inc | 510(k) number | 2010-01-06 | Not classified | Software design | Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values. | 28 | 2012-04-20 |
| Toshiba American Medical Systems Inc | 510(k) number | 2010-01-05 | Not classified | Other | Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction setting. Images acquired using the endo-ca | 27 | 2012-02-29 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-09-16 | Not classified | Software design | Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer. When an image is transferred from this s | 22 | 2012-03-21 |
| Toshiba American Medical Systems Inc | 510(k) number | 2009-05-11 | Not classified | Device Design | Toshiba America Medical Systems Inc is removing the PET-511BTM Multi-plane Transesophageal Transducer from the market after receiving several reports of injury regarding the transducer. Bending or buckling of the flexible portion of the P | 70 | 2012-03-22 |
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.