HM70 EVO
HM70 EVO is a mobile ultrasound system for diagnostic imaging and fluid-flow analysis. Its software acquires and displays ultrasound data, measures anatomical structures and provides…
HM70 EVO is a mobile ultrasound system for diagnostic imaging and fluid-flow analysis. Its software acquires and displays ultrasound data, measures anatomical structures and provides analysis packages for qualified healthcare professionals.
The system combines conventional 2D and M-mode imaging with color, power and spectral Doppler. Other modes include tissue Doppler, harmonic and panoramic imaging, elastography, freehand 3D and real-time 4D imaging.
Examination and Display Functions
Images can be shown in combined modes or dual and quad layouts. The system supports examinations including lung imaging and includes the CA4-10M transducer among its probe options. A real-time acoustic output display automatically presents mechanical and thermal indices. HM70 EVO is intended for hospitals, including emergency rooms, clinics and similar care settings.
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) | K210713 |
| Record published | 2021-08-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| USS-M7ENCC0/US | In distribution | |
| USS-M7ENN10/US | In distribution | |
| USS-M7ENN1B/US | In distribution | |
| USS-M7EPF30/US | In distribution | |
| USS-M7EPCC0/US | In distribution | |
| USS-M7ENFC0/US | In distribution | |
| USS-M7ENL10/US | In distribution | |
| USS-M7ENC30/US | In distribution | |
| USS-M7ENLC0/US | In distribution | |
| USS-M7EPC30/US | In distribution | |
| USS-M7EPFCB/US | In distribution | |
| USS-M7ENF30/US | In distribution | |
| USS-M7ENN30/US | In distribution | |
| USS-M7ENL30/US | In distribution | |
| USS-M7ENNC0/US | In distribution | |
| USS-M7EPF30/US | In distribution | |
| USS-M7EPF10/US | In distribution | |
| USS-M7ENF10/US | In distribution | |
| USS-M7ENCCB/US | In distribution | |
| USS-M7ENL1B/US | In distribution | |
| USS-M7EPC10/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.