Acuson Maple Select Diagnostic Ultrasound System
Catalogue number 11711779, listed by Siemens Medical Solutions USA, Inc., United States, under System, Imaging, Pulsed Echo, Ultrasonic. 37 manufacturers in China are registered for this product code.
37manufacturers in China registered for this device type
1catalogue number
31510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (9), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | 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 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Showing 12 of 37. All 37 manufacturers in China registered for System, Imaging, Pulsed Echo, Ultrasonic
Record
| Listed by | Siemens Medical Solutions USA, Inc., United States |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K232617 |
| Record published | 2023-11-29 |
| Record revised | 2025-11-24 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11711779 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hitachi | Hitachi, Ltd. | 224 |
| eTRAX™ Needle | Civco Medical Instruments Co., Inc. | 43 |
| BladderScan® | Verathon Inc. | 38 |
| Verza Guidance System | Civco Medical Instruments Co., Inc. | 37 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 34 |
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 34 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 33 |
| Tracking Bracket Starter Kit | Civco Medical Instruments Co., Inc. | 29 |
| System, Imaging, Pulsed Echo, Ultrasonic | GE Healthcare Japan Corporation | 23 |
| eTRAX™ Needle System Starter Kit | Civco Medical Instruments Co., Inc. | 20 |
| Tracking Bracket | Civco Medical Instruments Co., Inc. | 19 |
| Logiq | GE Ultrasound Korea, Ltd. | 18 |
Showing 12 of 805. All products under System, Imaging, Pulsed Echo, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233613 | 2024-06-12 |
| K211726 | 2021-11-05 |
| K142395 | 2014-09-09 |
| K072676 | 2007-12-18 |
| K071314 | 2007-05-22 |
| K063085 | 2006-11-14 |
| K042833 | 2004-10-27 |
| K040502 | 2004-03-09 |
| K992046 | 1999-08-13 |
| K981528 | 1998-10-28 |
| K981626 | 1998-05-27 |
| K962142 | 1997-05-29 |
| K962882 | 1997-04-24 |
| K961833 | 1996-10-29 |
| K950157 | 1996-04-05 |
| K946179 | 1995-10-03 |
| K896480 | 1990-07-13 |
| K894806 | 1989-10-05 |
| K863338 | 1986-11-24 |
| K863043 | 1986-11-10 |
| K863041 | 1986-11-10 |
| K863096 | 1986-11-10 |
| K860123 | 1986-07-07 |
| K854668 | 1986-03-20 |
| K854667 | 1986-03-20 |
| K852686 | 1986-03-10 |
| K853946 | 1986-01-16 |
| K853008 | 1986-01-13 |
| K852570 | 1985-09-19 |
| K852571 | 1985-09-19 |
| K844449 | 1985-01-23 |
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 | 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 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 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 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2015-01-12 | Class II | Vendor change control | There is a low probability the scanner arm will become completely detached from the scanner column. | 24 units | 2015-06-10 |
| 2013-01-18 | Class II | Process design | On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. | 214 affected devices | 2013-07-16 |
| 2012-05-11 | Class II | Other | In some cases, the system is unable to capture a clip or image during a routine scan. | 186 devices | 2015-05-06 |
| 2012-04-23 | Not classified | Software change control | 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. | 2013-07-16 | |
| 2012-04-23 | Not classified | Software change control | 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. | 2013-07-16 | |
| 2009-10-02 | Not classified | Nonconforming Material/Component | ECG waveform does not accurately align with 2D, M-Mode or Spectral Images. | 67 units total | 2011-03-29 |
| 2009-07-24 | Not classified | Software design | Product Failure– When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down. | 70 units | 2011-04-25 |
| 2009-07-24 | Not classified | Software design | Mistreatment risk– when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system. | 154 units | 2011-05-09 |
| 2009-04-07 | Not classified | Software design | Device function failure–When performing a TEE exam with the transducer, CW (Continuous Wave) mode is not functional. Due to work flow, this may not be apparent until the transducer is inserted into the patient’s esophagus. | 61 units | 2011-04-05 |
| 2008-06-06 | Not classified | Process control | The product assembly can cause a failure of the transducer which results in a double and/or overlapped image which may ultimately result in misleading or false information, inability to accurately diagnose, incorrect positioning/locating/in | 388 units | 2010-12-21 |
| 2008-03-21 | Not classified | Software design | Software issue may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis. | 51 active units total | 2009-09-30 |
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.