Resona I9W Diagnostic Ultrasound System
Resona I9W Diagnostic Ultrasound System is a mobile, software-controlled imaging system for trained healthcare professionals in hospitals or clinics. It acquires and displays ultrasound…
Resona I9W Diagnostic Ultrasound System is a mobile, software-controlled imaging system for trained healthcare professionals in hospitals or clinics. It acquires and displays ultrasound images and provides measurements and analysis of anatomy and fluid flow.
Imaging modes include B-mode, M-mode, pulsed and continuous-wave Doppler, color and power Doppler, tissue harmonics and three-dimensional imaging. The family also supports elastography and specified contrast-imaging applications.
Patient and Examination Range
The system is applicable to adults, pregnant patients, children and neonates. Examination areas include fetal, abdominal, cardiac, vascular, musculoskeletal and small-organ imaging, as well as specified intracavitary and intraoperative applications. Clinical interpretation remains with the qualified healthcare professional.
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) | K240684 |
| Record published | 2025-02-08 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Resona I9W | 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.