SonoSite M-Turbo
M-Turbo Ultrasound System, 1.9.2
44manufacturers in China registered for this device type
18catalogue numbers in this listing
1recall
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 | Fujifilm Sonosite,inc., United States |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K130173 |
| Record published | 2017-10-24 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Handling environment temperature -20 to 60 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 15 to 95 % RH; Storage environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P17000-13C | In distribution | |
| P17000-25R | In distribution | |
| P17000-18 | In distribution | |
| P08189-96 | In distribution | |
| P30397-15 | In distribution | |
| P17000-18C | In distribution | |
| P08189-86R | In distribution | |
| P17000-13Â | In distribution | |
| 1 | In distribution | |
| P17000-25C | In distribution | |
| P08189-85R | In distribution | |
| P28965-25 | In distribution | |
| P08189-90 | In distribution | |
| P08189-87R | In distribution | |
| P28965-25C | In distribution | |
| P08189-92 | In distribution | |
| P08189-32R | In distribution | |
| P17000-45 | In distribution |
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
4 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 | Closed |
|---|---|---|---|---|---|---|---|
| Fujifilm Sonosite,inc. | 510(k) number | 2013-09-11 | Class II | Error in labeling | FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended. | 10 units | 2013-12-11 |
| Fujifilm Sonosite,inc. | 510(k) number | 2011-07-18 | Not classified | Software design | This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment. | 4236 units (US) and 4089 units (internationally) | 2012-09-14 |
| Fujifilm Sonosite,inc. | 510(k) number | 2010-05-27 | Not classified | Nonconforming Material/Component | PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment. | 26 | 2011-04-18 |
| Fujifilm Sonosite,inc. | 510(k) number | 2008-08-08 | Not classified | Other | The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately r | 357 units | 2011-08-24 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-12-12 | Not classified | Other | 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides. | 355 boxes/24 kits per box | 2006-07-31 |
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.