System, Imaging, Pulsed Echo, Ultrasonic
P6D-RS
37manufacturers in China registered for this device type
4catalogue 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 | GE Vingmed Ultrasound A/S, Norway |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K142323 |
| Record published | 2016-07-15 |
| Record revised | 2026-04-29 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 45 °C; Handling environment temperature -40 to 70 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 30 to 95 % RH; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6Tc | In distribution | |
| P6D-RS | In distribution | |
| P6D | In distribution | |
| 9T-RS | 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
12 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 |
|---|---|---|---|---|---|---|---|
| GE Vingmed Ultrasound A/S | 510(k) number | 2024-05-02 | Class II | Device Design | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the in | 7 units | |
| GE Vingmed Ultrasound A/S | 510(k) number | 2024-05-02 | Class II | Device Design | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the in | 1 unit | |
| GE Vingmed Ultrasound A/S | 510(k) number | 2023-05-30 | Class II | Process design | GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations. | 2 units | |
| GE Vingmed Ultrasound A/S | 510(k) number | 2023-05-30 | Class II | Process design | GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations. | 14 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-11-10 | Class II | Device Design | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. | 5,649 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-11-10 | Class II | Device Design | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. | 5,145 units | |
| GE Medical Systems, LLC | 510(k) number | 2019-07-02 | Class II | Device Design | Potential for a transducer mis-alignment in certain transvaginal probes. | 3 devices | 2020-10-05 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics LLC | 510(k) number | 2018-03-22 | Class II | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. | 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS) | 2021-08-24 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics LLC | 510(k) number | 2018-03-22 | Class II | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. | 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS) | 2021-08-24 |
| GE Medical Systems Ultrasound and Primary Care Diagnostics LLC | 510(k) number | 2018-03-22 | Class II | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. | 12,426 (4,717 US; 7,709 OUS ALL PRODUCTS) | 2021-08-24 |
| GE Medical Systems, LLC | 510(k) number | 2017-03-10 | Class II | Software design | GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound sy | 971(412 US; 559 OUS) | 2018-03-12 |
| GE Medical Systems, LLC | 510(k) number | 2017-03-10 | Class II | Software design | GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound sy | 396 (67 US; 329 OUS) | 2018-03-12 |
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.