Vscan
Vscan Air R3.1 for Android
22manufacturers in China registered for this device type
6catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (5), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | 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 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Shenzhen Viatom Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 22. All 22 manufacturers in China registered for System, Imaging, Pulsed Doppler, Ultrasonic
Record
| Listed by | GE Vingmed Ultrasound A/S, Norway |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K250087 |
| Record published | 2025-05-22 |
| Record revised | 2026-04-29 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 0 to 35 °C; Storage environment humidity 10 to 95 % RH; Handling environment humidity 10 to 95 % RH; Storage environment temperature -40 to 70 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Distribution end date | 2022-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Air R3 for iOS | In distribution | |
| Air R3.1 for Android | In distribution | |
| Air R2 CL | In distribution | |
| Air R3 for Android | In distribution | |
| Air SL | In distribution | |
| Gateway v.1.4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hisense | Qingdao Hisense Medical Co., Ltd. | 219 |
| Medisono | Medisono, LLC | 173 |
| SonoScape | Sonoscape Medical Corp. | 111 |
| Hisense | Qingdao Hisense Medical Equipment Co., Ltd. | 92 |
| Diagnostic Ultrasound System | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 89 |
| Medistim Interconnect Cable | Medistim ASA | 40 |
| Compact Cart | Philips Ultrasound LLC | 30 |
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 27 |
| Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 25 |
| Logiq | GE Ultrasound Korea, Ltd. | 25 |
| Wisonic | Shenzhen Wisonic Medical Technology Co., Ltd. | 22 |
| Vivid | GE Vingmed Ultrasound A/S | 21 |
Showing 12 of 934. All products under System, Imaging, Pulsed Doppler, Ultrasonic
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. | |
| 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. | |
| 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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P940005 | 1996-04-11 | ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. |
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.