Acuson NX2 Elite Diagnostic Ultrasound System
The Acuson NX2 Elite is a mobile diagnostic ultrasound system that acquires ultrasound echo data and displays anatomical and flow information. It supports examinations across cardiac,…
The Acuson NX2 Elite is a mobile diagnostic ultrasound system that acquires ultrasound echo data and displays anatomical and flow information. It supports examinations across cardiac, abdominal, obstetric, vascular and other clinical applications.
Imaging modes include B-mode, M-mode, pulsed-wave and continuous-wave Doppler, color and tissue Doppler, harmonic imaging and three- or four-dimensional imaging. A flat-panel display presents the images and acoustic output indices.
Imaging and Analysis Options
The Elite configuration adds specified continuous-wave probes and software features to the NX2 platform. Measurement and analysis packages assist assessment of anatomical structures. An arterial health option measures carotid intima-media thickness and can display published reference information for clinician interpretation. Available functions depend on the installed probes and software.
22manufacturers in China registered for this device type
1catalogue number
75510(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 | Siemens Medical Solutions USA, Inc., 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, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K172374 |
| Record published | 2018-02-20 |
| Record revised | 2026-02-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11284500 | 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 |
| 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 |
|---|---|
| K260844 | 2026-06-16 |
| K253487 | 2025-11-17 |
| K253457 | 2025-11-13 |
| K251481 | 2025-08-20 |
| K242523 | 2024-11-19 |
| K243299 | 2024-11-15 |
| K240704 | 2024-07-22 |
| K233610 | 2024-06-12 |
| K232145 | 2023-10-30 |
| K232617 | 2023-09-26 |
| K230207 | 2023-02-13 |
| K223735 | 2023-02-06 |
| K221190 | 2022-08-16 |
| K221500 | 2022-06-14 |
| K213487 | 2022-02-11 |
| K211859 | 2021-07-20 |
| K210743 | 2021-04-01 |
| K202683 | 2020-10-15 |
| K201462 | 2020-06-24 |
| K201130 | 2020-05-26 |
| K200585 | 2020-04-22 |
| K200707 | 2020-04-15 |
| K200644 | 2020-04-10 |
| K193257 | 2020-01-31 |
| K192835 | 2019-10-22 |
| K191922 | 2019-08-15 |
| K181098 | 2018-05-31 |
| K180067 | 2018-02-07 |
| K173957 | 2018-02-01 |
| K180039 | 2018-02-01 |
| K172374 | 2017-08-15 |
| K163396 | 2017-01-04 |
| K161787 | 2016-07-28 |
| K150050 | 2015-02-09 |
| K142876 | 2014-10-23 |
| K141846 | 2014-08-07 |
| K140959 | 2014-04-30 |
| K131164 | 2013-12-24 |
| K130881 | 2013-10-11 |
| K130739 | 2013-06-06 |
| K130619 | 2013-03-21 |
| K123622 | 2012-12-05 |
| K123001 | 2012-10-26 |
| K122825 | 2012-09-28 |
| K121699 | 2012-06-22 |
| K111674 | 2011-06-30 |
| K102017 | 2010-09-20 |
| K093812 | 2010-03-03 |
| K083114 | 2009-03-31 |
| K070576 | 2007-03-26 |
| K063761 | 2007-01-04 |
| K063138 | 2006-11-22 |
| K061980 | 2006-08-17 |
| K061946 | 2006-07-21 |
| K052894 | 2005-11-23 |
| K052331 | 2005-11-10 |
| K052410 | 2005-09-22 |
| K051139 | 2005-05-13 |
| K050240 | 2005-02-15 |
| K050034 | 2005-01-13 |
| K043016 | 2004-11-16 |
| K042770 | 2004-10-20 |
| K042055 | 2004-08-16 |
| K042044 | 2004-08-13 |
| K041319 | 2004-06-07 |
| K040060 | 2004-01-28 |
| K033196 | 2003-10-16 |
| K032114 | 2003-07-21 |
| K032111 | 2003-07-18 |
| K023720 | 2002-11-20 |
| K003125 | 2000-10-20 |
| K001400 | 2000-08-01 |
| K980557 | 1998-04-24 |
| K945072 | 1995-11-21 |
| K945773 | 1995-08-07 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-01-28 | Class II | Software design | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined. The transit voltage values based on PW Doppler are calculated normally but not l | 1869 systems |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-01-28 | Class II | Software design | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined. The transit voltage values based on PW Doppler are calculated normally but not l | 70 systems |
Recalls
37 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-08-15 | Class II | Software design | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliter | 1990 | |
| 2024-08-15 | Class II | Software design | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliter | 7022 | |
| 2024-08-15 | Class II | Software design | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliter | 321 | |
| 2024-02-23 | Class II | Software design | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will | 67 | |
| 2024-02-23 | Class II | Software design | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will | 628 | |
| 2024-02-23 | Class II | Software design | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will | 5090 | |
| 2023-07-13 | Class II | Software design | If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing i | 796 | |
| 2022-03-07 | Class II | Process control | Transducers (component of ultrasound system) may exceed recommended thermal index limits | 31 units | |
| 2022-01-19 | Class II | Software design | The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk | 2846 | |
| 2021-11-12 | Class II | Software design | Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient’s condition. | 1161 systems | |
| 2021-07-12 | Class II | Software change control | Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable. | 15 systems | 2024-10-16 |
| 2021-02-04 | Class II | Software Design Change | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regar | 1,172 systems | |
| 2019-01-28 | Class II | Software design | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined. The transit voltage values based on PW Doppler are calculated normally but not l | 2262 systems | |
| 2019-01-28 | Class II | Software design | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined. The transit voltage values based on PW Doppler are calculated normally but not l | 1384 systems | |
| 2018-03-05 | Class II | Device Design | The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. | 229 systems | 2021-02-26 |
| 2018-01-26 | Class II | Under Investigation by firm | The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer. | 564 systems | 2020-07-02 |
| 2017-03-30 | Class II | Software design | When scanning with the 18L6 HD transducer on the ACUSON HELX” Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the apert | 2,045 systems | 2019-03-21 |
| 2016-11-07 | Class II | Device Design | Firm received reports about “acquisition errors” and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer. | 33 | 2017-05-26 |
| 2016-04-08 | Class II | Software design | While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of vie | 87 | 2017-01-18 |
| 2015-10-07 | Class II | Device Design | Siemens will provide all customers a new version of system software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will be implemented to address situations where the metal component used to engage the wheel lock | 2,099 units | 2017-10-19 |
| 2015-09-05 | Class II | Software design | Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to r | 4 | 2016-04-27 |
| 2015-08-19 | Class II | Software design | The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registr | 2039 devices | 2017-10-19 |
| 2015-06-29 | Class II | Under Investigation by firm | When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines. | 4140 total | 2018-01-18 |
| 2015-06-25 | Class II | Software Design Change | Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual Touch IQ region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral p | 629 units | 2017-10-19 |
| 2015-06-25 | Class II | Device Design | Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis. | 1789 units | 2017-10-19 |
| 2015-05-29 | Class II | Software design | When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study. | 573 devices | 2017-03-09 |
| 2015-01-12 | Class II | Component design/selection | The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position. | 230 | 2015-11-12 |
| 2014-06-03 | Class II | Software design | There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system. | 790 units | 2016-05-25 |
| 2014-04-23 | Class II | Software design | Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) – may incorrectly display the color flow data in the wrong position and when Doppler Frequency is adjusted, the system does not restart the pulsed wave Doppler | 257 units | 2015-11-12 |
| 2014-04-23 | Class II | Software design | Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could cause the need for the study to be repeated. | 177 units | 2015-11-12 |
| 2014-04-02 | Class II | Software Design Change | When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient’s date in the report. | 490 | 2015-11-12 |
| 2014-03-07 | Class II | Device Design | ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit. | 675 | 2015-11-12 |
| 2013-12-22 | Class II | Nonconforming Material/Component | The user interface assembly on the ACUSON SC2000 may become loose with the potential for the entire module to fall off of the ultrasound system. | 843 active units | 2015-05-06 |
| 2013-12-22 | Class II | Device Design | The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport. | 271 units | 2015-03-05 |
| 2013-07-10 | Class II | Device Design | Software issue results in inaccurate 3D image may result in ablation in wrong location. | 26 units | 2013-11-25 |
| 2013-03-28 | Class II | Device Design | When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is | 120 units | 2014-02-14 |
| 2012-07-11 | Class II | Other | In certain situations, loss of post exercise images can occur in Stress Echo. | 476 | 2015-05-06 |
| 2012-04-25 | Not classified | Software design | When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale. | 45 | 2012-10-19 |
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.