Lumify Ultrasound Circular Edition
Software version 3.x
22manufacturers in China registered for this device type
1catalogue number
51510(k) clearances naming this product code
40recalls on this 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 | Philips Ultrasound LLC, United States |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K203406 |
| Record published | 2022-08-10 |
| Record revised | 2024-06-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 795123 | 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 |
|---|---|
| K262311 | 2026-08-04 |
| K261211 | 2026-07-27 |
| K260667 | 2026-06-29 |
| K260123 | 2026-05-27 |
| K260680 | 2026-05-27 |
| K252558 | 2026-05-05 |
| K253595 | 2026-03-27 |
| K252557 | 2025-12-22 |
| K251651 | 2025-10-09 |
| K251455 | 2025-07-24 |
| K250886 | 2025-06-18 |
| K243793 | 2025-05-21 |
| K242519 | 2025-05-15 |
| K251110 | 2025-05-09 |
| K242670 | 2025-05-08 |
| K250030 | 2025-04-28 |
| K250177 | 2025-04-10 |
| K243794 | 2025-02-06 |
| K242020 | 2024-12-12 |
| K242800 | 2024-11-15 |
| K240980 | 2024-10-07 |
| K240850 | 2024-04-24 |
| K233788 | 2024-02-13 |
| K233545 | 2023-11-30 |
| K232500 | 2023-10-26 |
| K231190 | 2023-05-12 |
| K223771 | 2023-05-04 |
| K222648 | 2022-09-27 |
| K203406 | 2021-02-23 |
| K202216 | 2020-09-02 |
| K201012 | 2020-05-01 |
| K200304 | 2020-03-06 |
| K182857 | 2018-11-09 |
| K182529 | 2018-10-23 |
| K181485 | 2018-07-27 |
| K163120 | 2017-01-10 |
| K160807 | 2016-04-06 |
| K141369 | 2014-07-02 |
| K133833 | 2014-01-17 |
| K132304 | 2013-08-21 |
| K130499 | 2013-06-18 |
| K123754 | 2012-12-21 |
| K111513 | 2011-06-24 |
| K093563 | 2010-02-01 |
| K081661 | 2008-06-24 |
| K062247 | 2006-08-18 |
| K043535 | 2005-01-06 |
| K034003 | 2004-01-08 |
| K030455 | 2003-03-13 |
| K022303 | 2002-07-30 |
| K872817 | 1988-02-08 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips Ultrasound LLC | 510(k) number | 2025-10-31 | Class II | Software design | Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. | 4,819 systems |
| Philips Ultrasound LLC | 510(k) number | 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| Philips Ultrasound LLC | 510(k) number | 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
Recalls
39 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
| 2025-07-03 | Class III | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | 171,322 units |
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.