HS40 Diagnostic Ultrasound System
HS40 is a mobile diagnostic ultrasound system that acquires images and analyzes fluid flow. Software provides anatomical measurements and analysis packages for use by qualified healthcare…
HS40 is a mobile diagnostic ultrasound system that acquires images and analyzes fluid flow. Software provides anatomical measurements and analysis packages for use by qualified healthcare professionals under a licensed physician’s supervision.
Imaging options include two-dimensional, M-mode, color and spectral Doppler, tissue Doppler, harmonic, panoramic, freehand three-dimensional and real-time four-dimensional imaging. Elastoscan provides another imaging mode.
Clinical Range
Applications include obstetric, abdominal, gynecological, pediatric, cardiac, vascular, musculoskeletal and urological examinations. Mechanical and thermal acoustic-output indices are displayed automatically during real-time operation.
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 | Samsung Medison Co., 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) | K200339 |
| Record published | 2020-04-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| USS-HS4NB4D/US | In distribution | |
| USS-HS4NL4D/US | In distribution | |
| USS-HS4NL3D/US | In distribution | |
| USS-HS4PF3D/US | In distribution | |
| USS-HS4PF30/US | In distribution | |
| USS-HS4NL30/US | In distribution | |
| USS-HS4PB3D/US | In distribution | |
| USS-HS4PF4D/US | In distribution | |
| USS-HS4PB4D/US | In distribution | |
| USS-HS4NB3D/US | 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 |
|---|---|
| K261412 | 2026-07-28 |
| K254099 | 2026-03-27 |
| K252018 | 2026-01-05 |
| K250999 | 2025-07-18 |
| K243702 | 2025-02-12 |
| K242511 | 2024-12-10 |
| K242444 | 2024-11-27 |
| K241971 | 2024-10-11 |
| K240631 | 2024-06-21 |
| K240516 | 2024-06-12 |
| K233112 | 2023-12-21 |
| K231772 | 2023-10-03 |
| K230084 | 2023-04-21 |
| K223387 | 2023-02-13 |
| K221599 | 2022-08-22 |
| K220975 | 2022-06-29 |
| K221117 | 2022-06-17 |
| K220269 | 2022-05-06 |
| K220043 | 2022-04-05 |
| K211824 | 2021-09-09 |
| K211945 | 2021-09-08 |
| K210713 | 2021-07-09 |
| K210959 | 2021-06-24 |
| K210426 | 2021-05-13 |
| K210068 | 2021-04-09 |
| K202556 | 2020-10-30 |
| K200699 | 2020-05-07 |
| K200339 | 2020-04-07 |
| K192903 | 2020-01-06 |
| K192505 | 2019-12-12 |
| K192319 | 2019-12-10 |
| K192030 | 2019-09-19 |
| K191055 | 2019-06-12 |
| K191115 | 2019-06-12 |
| K190444 | 2019-05-22 |
| K182932 | 2019-02-15 |
| K182894 | 2019-01-22 |
| K182632 | 2019-01-08 |
| K182595 | 2018-12-18 |
| K181336 | 2018-12-04 |
| K180409 | 2018-05-11 |
| K173713 | 2018-03-08 |
| K173513 | 2018-02-20 |
| K173204 | 2018-02-05 |
| K171048 | 2017-08-24 |
| K171070 | 2017-08-09 |
| K172129 | 2017-08-08 |
| K170493 | 2017-03-28 |
| K163691 | 2017-02-22 |
| K153539 | 2016-10-03 |
| K162094 | 2016-08-26 |
| K153529 | 2016-02-02 |
| K153408 | 2015-12-21 |
| K152962 | 2015-11-02 |
| K151663 | 2015-08-12 |
| K150478 | 2015-03-26 |
| K143264 | 2014-12-09 |
| K143089 | 2014-11-26 |
| K142466 | 2014-10-03 |
| K141620 | 2014-07-02 |
| K133505 | 2013-12-27 |
| K133329 | 2013-11-27 |
| K132861 | 2013-10-04 |
| K130803 | 2013-04-12 |
| K122583 | 2012-09-05 |
| K113381 | 2011-12-29 |
| K112646 | 2011-10-12 |
| K112339 | 2011-08-29 |
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.