Logiq
LOGIQ E10s R2/R3 to R4 Upgrade with Hardware including Wireless
22manufacturers in China registered for this device type
25catalogue numbers in this listing
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 Ultrasound Korea, Ltd., South Korea |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Manufacturer |
| 510(k) | K231989 |
| Record published | 2024-12-23 |
| Record revised | 2026-07-22 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 18 to 30 °C; Storage environment temperature 14 to 122 °F; Handling environment temperature 64 to 86 °F; Storage environment temperature -10 to 50 °C |
| Distribution end date | 2025-10-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E10s R4 to R5 UPG | In distribution | |
| S8 R3 OLED | In distribution | |
| P9 R3 | In distribution | |
| Fortis R3 to R4 SW Upgrade W | In distribution | |
| S8 R4 LCD | In distribution | |
| S7 R2 to R3 UPG | In distribution | |
| S8 R3 to R4 UPG | In distribution | |
| S8 | In distribution | |
| P9 R2.5 to R3 UPG | In distribution | |
| P9 R2 to R2.5 UPG | In distribution | |
| S7 R3 | In distribution | |
| S8 R4 OLED | In distribution | |
| P10 R4 HD | In distribution | |
| E10s R2R3 to R4 HW Upgrade | In distribution | |
| P7 R2.5 to R3 UPG | In distribution | |
| E10s R2R3 to R4 HW Upgrade W | In distribution | |
| P8 R4 | In distribution | |
| Fortis R4 LCD | In distribution | |
| P10 R4.5 HD | In distribution | |
| Totus HDU | In distribution | |
| P10 R4 | In distribution | |
| Fortis R3 to R4 HW Upgrade | In distribution | |
| S7 R1 to R2 UPG | In distribution | |
| E10s R2R3 to R4 SW Upgrade W | In distribution | |
| P9 | 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 |
| Wisonic | Shenzhen Wisonic Medical Technology Co., Ltd. | 22 |
| Vivid | GE Vingmed Ultrasound A/S | 21 |
| HM70 EVO | Samsung Medison Co., Ltd. | 21 |
Showing 12 of 934. All products under System, Imaging, Pulsed Doppler, Ultrasonic
Recalls Naming This Product
5 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 Medical Systems, LLC | 510(k) number | 2025-09-18 | Class II | Software design | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. | 65 units | |
| GE Medical Systems, LLC | 510(k) number | 2025-09-18 | Class II | Software design | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. | 31 units | |
| GE Medical Systems, LLC | 510(k) number | 2025-09-18 | Class II | Software design | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. | 37 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, LLC | 510(k) number | 2019-07-02 | Class II | Device Design | Potential for a transducer mis-alignment in certain transvaginal probes. | 2 devices | 2020-10-05 |
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.