Voluson
BT12 Software Upgrade Kit for VS6
44manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 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 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| 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 |
Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic
Record
| Listed by | GE Ultrasound Korea, Ltd., South Korea |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Manufacturer |
| 510(k) | K250543 |
| Record published | 2025-06-04 |
| Record revised | 2020-02-12 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 50 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 18 to 30 °C; Storage environment humidity 30 to 80 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2024-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Performance 18 | In distribution | |
| S8 BT18 | In distribution | |
| S8t BT22 | In distribution | |
| Performance 16 | In distribution | |
| S10 Expert BT18 | In distribution | |
| S10 Expert BT22 | In distribution | |
| P8 BT16 | In distribution | |
| Signature 20 | In distribution | |
| P6 BT18 | In distribution | |
| Signature 20 BT27 | In distribution | |
| SWIFT+ BT23 | In distribution | |
| S6 BT12 to BT14 UPG | Withdrawn | |
| S6 BT14 to BT15 UPG | Withdrawn | |
| S8 BT14 to BT15 UPG | Withdrawn | |
| S6 BT11 to BT12 UPG | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 302 |
| Biopsy Starter Kit | Civco Medical Instruments Co., Inc. | 172 |
| Sheathes | Sheathing Technologies, Inc. | 170 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 156 |
| Sheathes3D | Sheathing Technologies, Inc. | 78 |
| Ultrasound Probe Cover Biopsy Needle Guide | Advance Medical Designs, Inc. | 78 |
| ultrasonic transducer | Edan Instruments, Inc. | 70 |
| Unbranded | Advance Medical Designs, Inc. | 68 |
| Reusable Biopsy Bracket | Protek Medical Products, Inc. | 60 |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | Advance Medical Designs, Inc. | 58 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 56 |
| Transducer Cover | Civco Medical Instruments Co., Inc. | 54 |
Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | UDI-DI | 2025-01-31 | Class II | Software design | For certain MR systems, a scan can be resumed following a Power Monitor trip when the “6-minute average SAR” is above the limit indicated on the “SAR Display”. The user interface may incorrectly enable a scan to proceed earlier than intende | 2538 | |
| GE Medical Systems, LLC | 510(k) number | 2019-07-02 | Class II | Device Design | Potential for a transducer mis-alignment in certain transvaginal probes. | 2 devices | 2020-10-05 |
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.