Diagnostic Ultrasound System
89 catalogue numbers from Recho R9 Lumi, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under System, Imaging, Pulsed Doppler, Ultrasonic. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
89catalogue numbers in this listing
83510(k) clearances naming this product code
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) | K250020 |
| Record published | 2025-11-27 |
| Record revised | 2026-01-20 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2026-01-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Recho R9 Lumi | In distribution | |
| MX3 BW | In distribution | |
| MX5 Pro | In distribution | |
| Consona EI | In distribution | |
| MU9S | In distribution | |
| MX3S | In distribution | |
| Consona ER | In distribution | |
| Crius R9 CV | In distribution | |
| MX6 Pro | In distribution | |
| Consona N5 Pro | In distribution | |
| MU9P | In distribution | |
| Emerus MX6 | In distribution | |
| MU9 Super | In distribution | |
| MXC | In distribution | |
| Anesus R9 CV | In distribution | |
| MX6T | In distribution | |
| Anesus MX6 Exp | In distribution | |
| MU9 | In distribution | |
| MU7 | In distribution | |
| Anesus MX6 | In distribution | |
| MX6 Exp | In distribution | |
| Emerus MX5 | In distribution | |
| MU9 Exp | In distribution | |
| Emerus MX5 Exp | In distribution | |
| MX3 Exp | In distribution | |
| Consona N5S | In distribution | |
| MU9A | In distribution | |
| MU7A | In distribution | |
| MX6 | In distribution | |
| MX5T | In distribution | |
| Recho R CV | In distribution | |
| MX5 Exp | In distribution | |
| Crius MX6 Exp | In distribution | |
| ACUSON Bonsai | In distribution | |
| MU7 Super | In distribution | |
| MU7 Exp | In distribution | |
| Crius MX5 | In distribution | |
| MX6 Super | In distribution | |
| Crius MX5 Exp | In distribution | |
| Consona N3 | In distribution | |
| Consona N5 Super | In distribution | |
| MX3 | In distribution | |
| Consona EF | In distribution | |
| Emerus MX6 Exp | In distribution | |
| MX3 Pro | In distribution | |
| MX5S | In distribution | |
| MU9 Pro | In distribution | |
| MU7T | In distribution | |
| Recho R CVx | In distribution | |
| MU7S | In distribution | |
| Consona N5 Exp | In distribution | |
| Anesus MX5 | In distribution | |
| MX3T | In distribution | |
| MX6S | In distribution | |
| MX2 BW | In distribution | |
| MXI | In distribution | |
| Consona N5 Ultra | In distribution | |
| Crius MX6 | In distribution | |
| MX2 | In distribution | |
| MU7 Pro | In distribution | |
| MU9T | In distribution | |
| MX5 Super | In distribution | |
| Nuda | In distribution | |
| Consona N5 Elite | In distribution | |
| MX5 | In distribution | |
| MXG | In distribution | |
| Anesus MX5 Exp | In distribution | |
| Malody | In distribution | |
| MX3 Super | In distribution | |
| Consona N3 Exp | In distribution | |
| MU7P | In distribution | |
| Aquila | In distribution | |
| Crius M11 | Withdrawn | |
| M10 | Withdrawn | |
| DC-40 Pro | Withdrawn | |
| M11CV | Withdrawn | |
| Z60T | Withdrawn | |
| Z60 | Withdrawn | |
| Operus M11 | Withdrawn | |
| CRIUS M10 | Withdrawn | |
| M9 PREMIUM | Withdrawn | |
| Z60S | Withdrawn | |
| M11 | Withdrawn | |
| Z60 PRO | Withdrawn | |
| TE5 MAX | Withdrawn | |
| TE9 | Withdrawn | |
| DP-60 | Withdrawn | |
| Consona N5 | Withdrawn | |
| TE7 Max | Withdrawn |
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 |
| 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 |
| HM70 EVO | Samsung Medison Co., Ltd. | 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.