Diagnostic Ultrasound System
17 catalogue numbers from Nano L12 EXP, listed by Edan Instruments, Inc., China, under System, Imaging, Pulsed Doppler, Ultrasonic. 22 manufacturers in China are registered for this product 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 | Edan Instruments, Inc., China |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K251268 |
| Record published | 2026-03-09 |
| Record revised | 2024-09-30 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Nano L12 EXP | In distribution | |
| Acclarix AX9 Basic | In distribution | |
| Acclarix AX9 | In distribution | |
| Nano C5 | In distribution | |
| Acclarix AX8 Super | In distribution | |
| Nano C5 EXP | In distribution | |
| Acclarix AX85 | In distribution | |
| Nano L12 | In distribution | |
| Acclarix AX78 | In distribution | |
| Acclarix AX9 Exp | In distribution | |
| Acclarix AX88 | In distribution | |
| Acclarix AX9 Super | In distribution | |
| Acclarix AX75 | In distribution | |
| Acclarix AX8 Exp | In distribution | |
| DUS-5000 | In distribution | |
| Acclarix LX9 | In distribution | |
| P10 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251268 | 2025-12-23 |
| K250214 | 2025-02-20 |
| K202856 | 2021-01-25 |
| K192879 | 2020-05-21 |
| K180862 | 2018-05-24 |
| K180408 | 2018-04-13 |
| K173003 | 2017-11-15 |
| K172380 | 2017-09-29 |
| K171900 | 2017-08-18 |
| K162055 | 2017-01-31 |
| K160790 | 2016-04-04 |
| K142511 | 2015-02-20 |
| K123249 | 2013-02-08 |
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.