Ultrasound System Sonimage HS1
The SONIMAGE HS1 is a portable ultrasound system for diagnostic imaging of body structures and fluid flow. Clinical applications include small parts, abdominal, obstetric, gynecological,…
The SONIMAGE HS1 is a portable ultrasound system for diagnostic imaging of body structures and fluid flow. Clinical applications include small parts, abdominal, obstetric, gynecological, musculoskeletal, peripheral vascular and cardiac examinations.
The system uses pulse echo ultrasound and supports B and M mode, color and pulsed wave Doppler and elastography. A compatible sector transducer also enables continuous wave Doppler, anatomical M mode and tissue Doppler functions.
Operation and Restrictions
The system displays thermal and mechanical output indices and can connect to a network by Ethernet or an optional wireless adapter. It is intended for qualified medical personnel and is contraindicated for examinations through the eyeball or direct contact with central nervous or cardiac structures.
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 | Konica Minolta, Inc., Japan |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K162065 |
| Record published | 2016-11-09 |
| Record revised | 2023-02-03 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A9RP | In distribution | |
| AC7G | In distribution | |
| A7AP | In distribution | |
| A8AR | In distribution | |
| AC7J | In distribution | |
| AC7H | In distribution | |
| A8WA | 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 |
|---|---|
| K220993 | 2022-06-23 |
| K162065 | 2016-10-19 |
| K152577 | 2015-10-08 |
| K142197 | 2014-11-21 |
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 |
|---|---|---|---|---|---|---|---|
| Konica Minolta Medical Imaging USA, Inc. | 510(k) number | 2017-12-04 | Class II | Device Design | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result. | 88 | 2019-10-28 |
| Konica Minolta Medical Imaging USA, Inc. | 510(k) number | 2017-12-04 | Class II | Device Design | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result. | 85 | 2019-10-28 |
| Konica Minolta Medical Imaging USA, Inc. | 510(k) number | 2017-12-04 | Class II | Device Design | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result. | 30 | 2019-10-28 |
| Konica Minolta Medical Imaging USA, Inc. | 510(k) number | 2017-12-04 | Class II | Device Design | There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result. | 17 | 2019-10-28 |
| Konica Minolta, Inc. | 510(k) number | 2017-04-24 | Class II | Software design | The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate. | 36 units | 2018-01-24 |
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.