Clarius Ultrasound Scanner
Clarius is a portable ultrasound family that uses wireless transducers with a smartphone or tablet display. Piezoelectric material sends high-frequency sound into the body and converts…
Clarius is a portable ultrasound family that uses wireless transducers with a smartphone or tablet display. Piezoelectric material sends high-frequency sound into the body and converts returning echoes into electronic signals used to form images.
The scanner communicates with an iOS or Android device running the Clarius app through direct Wi-Fi, with Bluetooth also part of the wireless system. Qualified healthcare practitioners use it for diagnostic imaging and fluid-flow analysis.
Listed Item
The Clarius 2-in-1 Charging Station HD is a charging station that combines a dock for charging HD Scanners, that has a separate port for charging a spare HD battery.
Scanner and Accessory Roles
The family includes different transducer models and accessories such as chargers and fans. A listed charging station is an accessory to the scanner system. Imaging modes include B-mode, M-mode and Doppler modes; the external mobile device provides the image display.
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 | Clarius Mobile Health Corp., Canada |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K213436 |
| Record published | 2022-09-29 |
| Record revised | 2018-12-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Clarius Scanner L15 HD3 | In distribution | |
| Clarius Scanner L20 HD3 | In distribution | |
| C3-45 Premium Non-Commercial ARTHREX | In distribution | |
| Clarius Fan HD3 | In distribution | |
| Battery – ARTHREX | In distribution | |
| Clarius Charger HD | In distribution | |
| L7 HD | In distribution | |
| C7 HD | In distribution | |
| L7 Premium | In distribution | |
| Clarius Scanner C7 HD3 | In distribution | |
| Clarius Scanner EC7 HD3 | In distribution | |
| C3 HD | In distribution | |
| C3-60 Premium | In distribution | |
| Clarius 2-in-1 Charging Station HD | In distribution | |
| L15 HD | In distribution | |
| L20 HD | In distribution | |
| L7 Premium Non-Commercial ARTHREX | In distribution | |
| Clarius Charger HD3 | In distribution | |
| Clarius Scanner C3 HD3 | In distribution | |
| C3-45 Premium | In distribution | |
| L7 | In distribution | |
| Clarius Scanner L7 HD3 | In distribution | |
| Clarius Scanner PA HD3 | In distribution | |
| Clarius Scanner PAL HD3 | In distribution | |
| PA HD | 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 |
| Logiq | GE Ultrasound Korea, Ltd. | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233955 | 2024-06-14 |
| K232704 | 2023-10-05 |
| K213436 | 2021-11-15 |
| K192107 | 2019-08-29 |
| K180799 | 2018-05-14 |
| K172385 | 2017-09-14 |
| K163138 | 2016-11-30 |
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.