H-Universal Stand
3 catalogue numbers from P30377-01, listed by Fujifilm Sonosite,inc., United States, under System, Imaging, Pulsed Doppler, Ultrasonic. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
3catalogue numbers in this listing
25510(k) clearances naming this product code
6recalls 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 | Fujifilm Sonosite,inc., United States |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K162045 |
| Record published | 2022-10-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 15 to 95 % RH; Handling environment temperature -35 to 65 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 15 to 95 % RH; Storage environment temperature -35 to 65 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P30377-01 | In distribution | |
| P23119-25A | In distribution | |
| P12163-55 | In distribution |
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 |
|---|---|
| K260595 | 2026-03-10 |
| K253448 | 2025-11-03 |
| K251106 | 2025-08-29 |
| K251830 | 2025-07-10 |
| K233597 | 2023-12-06 |
| K213763 | 2021-12-27 |
| K202160 | 2020-09-01 |
| K200964 | 2020-05-08 |
| K190476 | 2019-03-15 |
| K183235 | 2019-02-07 |
| K180704 | 2018-04-13 |
| K171437 | 2017-06-12 |
| K162288 | 2016-09-08 |
| K162045 | 2016-08-18 |
| K161119 | 2016-05-13 |
| K160674 | 2016-04-19 |
| K160734 | 2016-04-05 |
| K160406 | 2016-03-16 |
| K153626 | 2016-01-20 |
| K152983 | 2015-11-12 |
| K152209 | 2015-08-19 |
| K142017 | 2014-08-22 |
| K133454 | 2013-12-16 |
| K133134 | 2013-11-04 |
| K130173 | 2013-03-25 |
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 |
|---|---|---|---|---|---|
| 2010-08-13 | Not classified | Software design | Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the “print” command is selected. As a result, the displayed MI or TI values may be incorrect. | 69 | 2011-07-21 |
| 2007-11-02 | Not classified | Process control | Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer. | 38 units | 2010-10-05 |
| 2007-11-02 | Not classified | Process control | Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer. | 16 units | 2010-10-05 |
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.