Resona I8 Easi Diagnostic Ultrasound System
Resona I8 Easi is a mobile ultrasound system for diagnostic imaging, measurement and analysis in hospitals and medical clinics. Trained healthcare professionals use it for adults, pregnant…
Resona I8 Easi is a mobile ultrasound system for diagnostic imaging, measurement and analysis in hospitals and medical clinics. Trained healthcare professionals use it for adults, pregnant patients, children and neonates. Its applications include fetal, abdominal, cardiac, vascular, musculoskeletal and urologic examinations.
The system sends ultrasound into the body and processes returning echoes to show anatomy and fluid flow. B and M imaging, Doppler modes and combined views provide information for the examination. Measurement tools and analysis packages support the clinician’s interpretation.
Imaging Options
Supported modes include tissue harmonic imaging, real time three dimensional imaging and strain elastography. Contrast imaging is available for specified cardiac and liver applications. The transducer and selected examination setup determine the applicable functions.
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 | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K240115 |
| Record published | 2025-02-14 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Resona I8 Easi | 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 |
|---|---|
| K260846 | 2026-05-11 |
| K253049 | 2026-02-11 |
| K251601 | 2025-12-03 |
| K251853 | 2025-11-07 |
| K251820 | 2025-09-12 |
| K251250 | 2025-09-05 |
| K251192 | 2025-08-22 |
| K250024 | 2025-05-30 |
| K250020 | 2025-05-19 |
| K250110 | 2025-05-16 |
| K242231 | 2024-11-08 |
| K241201 | 2024-09-16 |
| K241432 | 2024-09-12 |
| K240906 | 2024-07-23 |
| K240684 | 2024-06-17 |
| K240115 | 2024-04-22 |
| K231685 | 2023-10-26 |
| K230768 | 2023-06-09 |
| K222928 | 2023-02-07 |
| K221300 | 2022-09-29 |
| K221496 | 2022-09-29 |
| K220242 | 2022-03-25 |
| K220051 | 2022-03-04 |
| K212265 | 2021-11-16 |
| K212900 | 2021-11-05 |
| K211337 | 2021-07-01 |
| K210699 | 2021-06-10 |
| K210416 | 2021-06-10 |
| K203391 | 2021-03-23 |
| K201990 | 2020-11-09 |
| K201693 | 2020-08-21 |
| K200643 | 2020-07-24 |
| K200979 | 2020-05-28 |
| K200001 | 2020-04-09 |
| K200411 | 2020-04-08 |
| K200251 | 2020-04-02 |
| K192410 | 2019-12-19 |
| K192152 | 2019-12-13 |
| K183660 | 2019-04-09 |
| K183377 | 2019-04-04 |
| K190206 | 2019-03-08 |
| K182636 | 2019-01-10 |
| K181637 | 2019-01-09 |
| K182603 | 2018-11-14 |
| K180912 | 2018-07-30 |
| K173471 | 2018-01-08 |
| K172860 | 2018-01-02 |
| K172970 | 2017-10-25 |
| K171579 | 2017-10-18 |
| K171891 | 2017-09-21 |
| K171034 | 2017-07-10 |
| K163690 | 2017-04-20 |
| K170277 | 2017-03-23 |
| K162845 | 2016-12-15 |
| K162267 | 2016-09-06 |
| K161525 | 2016-07-13 |
| K160381 | 2016-03-09 |
| K152543 | 2015-10-29 |
| K152763 | 2015-10-21 |
| K152545 | 2015-10-02 |
| K150080 | 2015-06-12 |
| K150204 | 2015-04-10 |
| K143472 | 2015-01-02 |
| K141010 | 2014-05-14 |
| K140030 | 2014-02-19 |
| K132779 | 2013-11-19 |
| K132341 | 2013-08-15 |
| K130833 | 2013-06-21 |
| K130695 | 2013-06-19 |
| K123503 | 2012-12-13 |
| K122010 | 2012-07-20 |
| K121010 | 2012-04-19 |
| K120699 | 2012-04-19 |
| K113647 | 2011-12-16 |
| K110199 | 2011-02-08 |
| K103677 | 2011-01-31 |
| K103583 | 2010-12-27 |
| K100830 | 2010-05-05 |
| K083505 | 2008-12-12 |
| K083001 | 2008-10-22 |
| K081320 | 2008-05-27 |
| K080640 | 2008-03-21 |
| K063500 | 2006-12-06 |
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.