HM70 EVO Diagnostic Ultrasound System
The HM70 EVO is a mobile, software controlled diagnostic ultrasound system for acquiring images and analyzing fluid flow. It supports examinations across areas such as the abdomen,…
The HM70 EVO is a mobile, software controlled diagnostic ultrasound system for acquiring images and analyzing fluid flow. It supports examinations across areas such as the abdomen, pregnancy, heart, musculoskeletal system, peripheral vessels, lungs and dermatology.
Imaging modes include two dimensional and M mode views, color and spectral Doppler, harmonic imaging, elastography and three or four dimensional imaging. The system also provides measurements of anatomical structures and analysis packages to support professional diagnosis.
Clinical Operation
The display automatically shows mechanical and thermal indices for acoustic output. The system is intended for appropriately trained healthcare professionals in hospitals, emergency departments, clinics, private practices and similar care settings. Available imaging combinations support different clinical examinations.
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) | K233112 |
| Record published | 2024-01-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| USS-M7EVN1C/US | In distribution | |
| USS-M7EPFCC/US | In distribution | |
| USS-M7EPF1C/US | In distribution | |
| USS-M7ENC1C/US | In distribution | |
| USS-M7ENF1C/US | In distribution | |
| USS-M7ENCCC/US | In distribution | |
| USS-M7EPCCC/US | In distribution | |
| USS-M7EPC1C/US | In distribution | |
| USS-M7ENNCC/US | In distribution | |
| USS-M7ENLCC/US | In distribution | |
| USS-M7EVC1C/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.