Hisense
92 catalogue numbers from HD59, listed by Qingdao Hisense Medical Equipment Co., Ltd., China, under System, Imaging, Pulsed Doppler, Ultrasonic. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
92catalogue numbers in this listing
3510(k) clearances naming this product 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 | Qingdao Hisense Medical Equipment Co., Ltd., China |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Manufacturer |
| 510(k) | K213862 |
| Record published | 2022-07-05 |
| Record revised | 2024-05-27 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HD59 | In distribution | |
| DC7-2E | In distribution | |
| HD60 Exp | In distribution | |
| E9-4EL | In distribution | |
| P8-2E | In distribution | |
| HD38Plus | In distribution | |
| P5-1A | In distribution | |
| L12-3E | In distribution | |
| HD40G | In distribution | |
| HD58 Plus | In distribution | |
| HD82 | In distribution | |
| SC7-1E | In distribution | |
| HD62 Pro | In distribution | |
| L9-3A | In distribution | |
| P8-2EJ | In distribution | |
| E9-4E | In distribution | |
| HD40E | In distribution | |
| XP5-1E | In distribution | |
| P4-1L | In distribution | |
| HD38S | In distribution | |
| HD61 Plus | In distribution | |
| HD40S | In distribution | |
| ECL11-4E | In distribution | |
| HD62 Plus | In distribution | |
| C6-1S | In distribution | |
| E9-4B | In distribution | |
| L12-4L | In distribution | |
| HD61 Pro | In distribution | |
| L9-3E | In distribution | |
| HD62 | In distribution | |
| HD62EXP (Version 2) | In distribution | |
| HD42 | In distribution | |
| HD60 Pro | In distribution | |
| P4-1E | In distribution | |
| HD40Plus | In distribution | |
| C5-2L | In distribution | |
| HD62 Exp | In distribution | |
| HD61 | In distribution | |
| HD42Plus (Version 2) | In distribution | |
| HD38Q | In distribution | |
| C5-2A | In distribution | |
| DE10-3E | In distribution | |
| HD38G | In distribution | |
| L15-5E | In distribution | |
| HD60 Plus | In distribution | |
| HD35Q | In distribution | |
| HD42G | In distribution | |
| HD38E | In distribution | |
| L12-3EB | In distribution | |
| HD40Q | In distribution | |
| HD59 Pro | In distribution | |
| MC9-4A | In distribution | |
| P4-1EB | In distribution | |
| L15-5EB | In distribution | |
| MC11-3A | In distribution | |
| HD59 Plus | In distribution | |
| HD58EXP (Version 2) | In distribution | |
| HD42E | In distribution | |
| DC7-2A | In distribution | |
| HD61 Exp | In distribution | |
| HD35E | In distribution | |
| HD58 | In distribution | |
| HD35G | In distribution | |
| HD40T | In distribution | |
| HD58 Exp | In distribution | |
| HD38 | In distribution | |
| HD78 | In distribution | |
| DC6-2A | In distribution | |
| HD42S | In distribution | |
| L15-5EL | In distribution | |
| HD60EXP (Version 2) | In distribution | |
| HD35 | In distribution | |
| HD75 | In distribution | |
| HD80 | In distribution | |
| HD42T | In distribution | |
| HD60 | In distribution | |
| HD38T | In distribution | |
| HD40 | In distribution | |
| E9-3E | In distribution | |
| C5-1E | In distribution | |
| P4-1EL | In distribution | |
| HD42Q | In distribution | |
| HD42Plus | In distribution | |
| E9-4L | In distribution | |
| HD59 Exp | In distribution | |
| SC8-2E | In distribution | |
| HD35S | In distribution | |
| L14-6E | In distribution | |
| HD35T | In distribution | |
| HD35Plus | In distribution | |
| L21-9E | In distribution | |
| HD58 Pro | 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 |
| 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 |
| HM70 EVO | Samsung Medison Co., Ltd. | 21 |
Showing 12 of 934. All products under System, Imaging, Pulsed Doppler, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233841 | 2024-05-16 |
| K233439 | 2024-02-21 |
| K213862 | 2022-06-08 |
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.