H-Universal Stand
Catalogue number P12163-16, listed by Fujifilm Sonosite,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
2recalls 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 | Fujifilm Sonosite,inc., United States |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K043452 |
| Record published | 2017-03-31 |
| 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; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 15 to 95 % RH; Storage environment temperature -35 to 65 °C; Handling environment temperature -35 to 65 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P12163-16 | 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
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 | 2007-02-05 | Not classified | Other | Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db. | 6 Devices | 2007-06-01 |
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 |
|---|---|---|---|---|---|
| 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 |
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.