Medisono
Single Crystal Convex Array Transducer Model PB-C1-5 FOR Medisono MS22 Plus
22manufacturers in China registered for this device type
173catalogue 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 | Medisono, LLC, United States |
|---|---|
| FDA product code | IYN |
| Device type | System, Imaging, Pulsed Doppler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1550 |
| Establishment | Repacker / relabeller |
| 510(k) | K172993 |
| Record published | 2020-12-28 |
| Record revised | 2026-03-23 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P25EXPERT | In distribution | |
| LINEAR ARRAY INTRAOPERATIVE PROBE MODEL 10L2 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| CONVEX ARRAY PROBE MODEL 3C-A FOR P10 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL 6CI-A FOR MEDISONO P11 PLUS | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL EC9-5 FOR P10 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L742UB FOR MEDISONO P10 & P10V | In distribution | |
| TRANSRECTAL ARRAY PROBE MODEL EC9-5 (UROLOGY) FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL L741FOR P10 PLUS | In distribution | |
| PHASED ARRAY (SINGLE CRYSTAL) PROBE MODEL S1-5 FOR MEDISONO P12 PLUS/P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L761-2 FOR MEDISONO P3 & P3V | In distribution | |
| LINEAR PROBE MODEL L742 FOR MEDISONO P25 EXPERT | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL C613 FOR MEDISONO P12EXP | In distribution | |
| BIPLANAR TRANSDUCER BCC9-5 (TWO CONVEX TRANSDUCERS) FOR MEDISONO MS 55 PLUS | In distribution | |
| LINEAR ARRAY PROBE PB-L742 FOR MEDISONO P11PLUS | In distribution | |
| TRANSVAGINAL PROBE MODEL PB-E611-2 FOR MEDISONO P3 | In distribution | |
| CONVEX VOLUMETRIC PROBE MODEL VC6-2 FOR MEDISONO P11 PLUS | In distribution | |
| PHASED ARRAY PROBE MODEL 2P1 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| PHASED ARRAY PROBE MODEL PB-7P-B FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L552UB FOR MEDISONO P10 & P10V (LONG CABLE) | In distribution | |
| PHASED ARRAY TRANSDUCER 4P-A FOR MEDISONO MS 55 PLUS | In distribution | |
| PHASED ARRAY PROBE MODEL S1-5 FOR MEDISONO P25 EXPERT | In distribution | |
| ENDOCAVITY CONVEX ARRAY PROBE MODEL EC9-5 FOR MEDISONO MS19 | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C361 FOR MEDISONO MS19 | In distribution | |
| LINEAR ARRAY (INTRA-OPERATIVE) PROBE MODEL 10I2 FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L1042UB FOR MEDISONO P10 & P10V | In distribution | |
| LAPAROSCOPE LINEAR ARRAY PROBE MODEL LAP7 FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL L742 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| CONVEX VOLUMETRIC PROBE MODEL PB-VC6-2 FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 P | In distribution | |
| INTRAOPERATIVE MODEL PB-6CT-A FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL 12LT-A FOR MEDISONO P11 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL C344 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| LINEAR ARRAY PROBE MODEL PB- 12L-B FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL L741 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| PHASED ARRAY (SINGLE CRYSTAL) PROBE MODEL S1-5 FOR MEDISONO P25 EXPERT | In distribution | |
| ENDOCAVITY ARRAY MODEL 6V1 FOR MEDISONO P11 PLUS | In distribution | |
| PENCIL PROBE MODEL CWD 2.0 FOR MEDISONO P25EXP | In distribution | |
| PHASED ARRAY PROBE MODEL 2P1 FOR MEDISONO MS19 / MS22 PLUS | In distribution | |
| PENCIL PROBE MODEL CWD 5.0 FOR MEDISONO P25EXP | In distribution | |
| LINEAR ARRAY PROBE MODEL 10I2 FOR P10 PLUS | In distribution | |
| PHASED ARRAY PROBE MODEL 3P-A FOR MS19PLUS & MS22PLUS | In distribution | |
| LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-12LI-A FOR MEDISONO P12 PLUS/P25 E | In distribution | |
| P10 | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V1 FOR P10 PLUS | In distribution | |
| CONVEX ARRAY PROBEMODEL PB-C5-2B FOR MEDISONO P10 | In distribution | |
| PHASED ARRAY PROBE MODEL 7P-B FOR MEDISONO P25 EXPERT | In distribution | |
| PHASED ARRAY TRANSDUCER 7P-A FOR MEDISONO MS 55 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C613 FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| MS22 PLUS COLOR DOPPLER DIAGNOSTIC ULTRASOUND SYSTEM (23.8‘’ SCREEN) | In distribution | |
| MS12 DIAGNOSTIC COLOR DOPPLER SYSTEM | In distribution | |
| LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-12LT-A FOR MEDISONO P12 PLUS/P25 E | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL PB-C612UB FOR MEDISONO P10 & P10V (LONG CABLE) | In distribution | |
| CONVEX ARRAY PROBE MODEL C322 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| LINEAR ARRAY MODEL PB-L752 FOR MEDISONO P11 PLUS | In distribution | |
| CONVEX PROBE MODEL PB-3C-A FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL C354 FOR MEDISONO P11 PLUS | In distribution | |
| PHASED ARRAY PROBE MODEL 2P2 FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL: PB-L15-7B FOR MEDISONO P10 | In distribution | |
| MS19 COLOR DOPPLER DIAGNOSTIC ULTRASOUND SYSTEM | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C361-2 FOR MEDISONO P3 & P3V (LONG CABLE) | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L761-2 FOR MEDISONO P3 & P3V (LONG CABLE) | In distribution | |
| CONVEX ARRAY PROBE MODEL C613 FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL L752 FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL L752 FOR MEDISONO P25EXP | In distribution | |
| PHASED ARRAY PROBE MODEL 5P1 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| CONVEX ARRAY PROBE MODEL C353 FOR MEDISONO P25EXP | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL: PB-6152UB FOR MEDISONO P10 | In distribution | |
| PEDOFF TRANSDUCER CWD2.0 (FOR CARDIAC) FOR MEDISONO MS 55 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C352UB FOR MEDISONO P10 & P10V | In distribution | |
| CONVEX ARRAY PROBE MODEL 6CT-A FOR P10 PLUS | In distribution | |
| P9 PLUS | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL PB-C422UB FOR MEDISONO P10 & P10V (LONG CABLE) | In distribution | |
| LINEAR ARRAY PROBE MODEL 12L-A FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL 9L-A FOR P10 PLUS | In distribution | |
| LINEAR ARRAY TRANSDUCER 9L-A (COMPOSITE CRYSTAL) FOR MEDISONO MS 55 PLUS | In distribution | |
| ENDOCAVITARY PROBE MODEL 6V3 FOR MEDISONO P25 EXPERT | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL PB-C612UB FOR MEDISONO P10 & P10V | In distribution | |
| TRANSRECTAL ARRAY PROBE MODEL EC9-5 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| P25EXP | In distribution | |
| LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL 12LI-A FOR MEDISONO P25 EXPERT | In distribution | |
| CWD PROBE MODEL CWD 2.0 FOR P10 PLUS | In distribution | |
| PHASED ARRAY PROBE MODEL P3-A FOR MEDISONO MS12 | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C1-6 FOR MEDISONO MS 55 PLUS | In distribution | |
| PHASED ARRARY MODEL 5P1 FOR MEDISONO P11 PLUS | In distribution | |
| INTERVENTIONAL MICRO-CONVEX ARRAY TRANSDUCER C322 FOR MEDISONO MS 55 PLUS | In distribution | |
| MICRO-CONVEX PROBE MODEL PB-C611-2 FOR MEDISONO P3 & P3V (LONG CABLE) | In distribution | |
| LINEAR ARRAY PROBE MODEL 12L-B FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L743-2 FOR MEDISONO P3 & P3V (LONG CABLE) | In distribution | |
| ENDORECTAL PROBE MODEL PB-V563-2 FOR MEDISONO P3V | In distribution | |
| PHASED ARRAY PROBE MODEL PB-P3-A FOR MEDISONO P9 PLUS & P3 PLUS | In distribution | |
| P3 PLUS | In distribution | |
| TRANSVAGINAL ARRAY PROBE MODEL PB-E612UB FOR MEDISONO P10 | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L742UB FOR MEDISONO P10 & P10V (LONG CABLE) | In distribution | |
| BIPLANE PROBE MODEL BCL 10-5 FOR MEDISONO P11 PLUS | In distribution | |
| VOLUMETRIC ENDOCAVITY PROBE MODEL PB-VE9-5 FOR MEDISONO MS55 | In distribution | |
| MS22 PLUS COLOR DOPPLER DIAGNOSTIC ULTRASOUND SYSTEM | In distribution | |
| INTRAOPERATIVE MODEL 6CT-A FOR MEDISONO P25 EXPERT | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V7 FOR MEDISONO P25EXP | In distribution | |
| BIPLANE PROBE MODEL PB-BCL10-5 FOR MEDISONO P11 PLUS | In distribution | |
| P12 PLUS DIGITAL COLOR DOPPLER SYSTEM | In distribution | |
| LINEAR TRANS RECTAL PROBE MODEL L7V-A FOR MEDISONO P9 PLUS & P3 PLUS | In distribution | |
| P10 PLUS DIAGNOSTIC COLOR DOPPLER SYSTEM | In distribution | |
| BIPLANE PROBE MODEL BCL FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL PB- 12L-A FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| P11EXP | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V7 FOR MEDISONO P11 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL C1-6 FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL 12LT-A FOR MEDISONO P25 EXPERT | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V1A FOR MEDISONO P12EXP & P25EXP | In distribution | |
| BIPLANE PROBE MODEL BCC9-5 FOR MEDISONO P11 PLUS | In distribution | |
| PHASED ARRAY (SINGLE CRYSTAL) PROBE MODEL S1-5 FOR MEDISONO MS 55 PLUS | In distribution | |
| VOLUMETRIC ENDOCAVITY PROBE MODEL PB-VE9-5 FOR MEDISONO P12 PLUS/P25 EXPERT /MS | In distribution | |
| VOLUMETRIC ENDOCAVITY PROBE MODEL VE9-5 FOR MEDISONO P25 EXPERT | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL MODEL: PB-6V7 FOR MEDISONO P12 PLUS/P25 EXPERT /MS | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C361-2 FOR MEDISONO P3 & P3V | In distribution | |
| CONVEX ARRAY MODEL C322 FOR MEDISONO P11 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL 3C-A FOR MEDISONO P12EXP & P25EXP | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V1 FOR MEDISONO P25 EXPERT | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL C611 FOR MEDISONO P11 PLUS | In distribution | |
| CONVEX VOLUMETRIC PROBE MODEL VC6-2 FOR MEDISONO P25 EXPERT | In distribution | |
| ENDOCAVITARY PROBE MODEL PB-6V3 FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| TRANSESOPHAGEAL MPTEE MINI PROBE FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL L743 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| LINEAR ARRAY MODEL PB- L743 FOR MEDISONO FOR P11 PLUS | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL PB-C422UB FOR MEDISONO P10 & P10V | In distribution | |
| TRANSESOPHAGEAL MPTEE PROBE FOR MEDISONO P25 EXPERT | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V1A FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L552UB FOR MEDISONO P10 & P10V | In distribution | |
| PHASED ARRAY PROBE MODEL 7P-B FOR P10 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL 12L-B FOR MEDISONO P25 EXPERT | In distribution | |
| BIPLANE PROBE MODEL PB- BCL10-5 FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| LAPAROSCOPE LINEAR ARRAY PROBE MODEL PB-LAP7 FOR MEDISONO P12 PLUS/P25 EXPERT | In distribution | |
| P12EXP | In distribution | |
| CONVEX PROBE MODEL 3C-A FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-9L-A FOR MEDISONO MS12 | In distribution | |
| PHASED ARRAY PROBE MODEL 3P_A FOR MEDISONO P25 EXPERT | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C1-6 FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| PENCIL PROBE MODEL PWD 2.0 FOR MEDISONO P25EXP | In distribution | |
| SINGLE CRYSTAL CONVEX ARRAY TRANSDUCER MODEL PB-C1-5 FOR MEDISONO MS22 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL L741 FOR MEDISONO P11 PLUS | In distribution | |
| TRANSVAGINAL ARRAY PROBE MODEL 6V3 FOR MEDISONO P11 PLUS | In distribution | |
| INTRAOPERATIVE PROBE MODEL PB-6CI-A FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLU | In distribution | |
| PHASED ARRAY (SINGLE CRYSTAL) PROBE MODEL S1-5 FOR MEDISONO P25 EXPERT | In distribution | |
| INTRAOPERATIVE PROBE MODEL 6CI-A FOR MEDISONO P25 EXPERT | In distribution | |
| CONVEX ARRAY PROBE MODEL C322 FOR P10 PLUS | In distribution | |
| PENCIL PROBE MODEL PB-CWD 2.0 FOR MEDISONO MS12 | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V3-A FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR PROBE MODEL L741 FOR MEDISONO P25 EXPERT | In distribution | |
| PHASED ARRAY PROBE MODEL PB-S1-5 FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 PLUS | In distribution | |
| LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL PB-10I2 FOR MEDISONO P12 PLUS/P25 EXP | In distribution | |
| MICRO-CONVEX ARRAY PROBE MODEL C613 FOR P10 PLUS | In distribution | |
| MICRO-CONVEX ARRAY C613 FOR MEDISONO P11 PLUS | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L743-2 FOR MEDISONO P3 & P3V | In distribution | |
| PHASED ARRAY PROBE MODEL 7P-B FOR MEDISONO MS12 | In distribution | |
| PHASED ARRAY PROBE MODEL: PB-P5-1B FOR MEDISONO P10 | In distribution | |
| LINEAR ARRAY (INTRAOPERATIVE) PROBE MODEL 10I2 FOR MEDISONO P25 EXPERT | In distribution | |
| LINEAR ARRAY PROBE MODEL PB-L1042UB FOR MEDISONO P10 & P10V (LONG CABLE) | In distribution | |
| LINEAR ARRAY PROBE MODEL 12LI-A FOR MEDISONO P11 PLUS | In distribution | |
| PHASED ARRAY PROBE MODEL 2P1 FOR MEDISONO P11 PLUS | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V3 FOR MEDISONO P25EXP | In distribution | |
| LAPAROSCOPE LINEAR ARRAY PROBE MODEL PB-LAP7 FOR MEDISONO P25EXP | In distribution | |
| P11PLUS | In distribution | |
| CONVEX ARRAY PROBE MODE 3C-A FOR MEDISONO P11 PLUS | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL 6V1 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL MODEL: 6V7 FOR MEDISONO P25 EXPERT | In distribution | |
| CONVEX VOLUMETRIC PROBE MODEL VC6-2 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| BIPLANE PROBE MODEL BCC9-5 FOR MEDISONO P12EXP & P25EXP | In distribution | |
| CONVEX ARRAY MODEL C353 FOR MEDISONO P11 PLUS | In distribution | |
| MS 55 PLUS COLOR DOPPLER DIAGNOSTIC ULTRASOUND SYSTEM | In distribution | |
| ENDOCAVITY ARRAY PROBE MODEL PB-6V3-A FOR MEDISONO P12 PLUS/P25 EXPERT /MS 55 P | In distribution | |
| MICRO-CONVEX PROBE MODEL PB-C611-2 FOR MEDISONO P3 | In distribution | |
| ENDORECTAL PROBE MODEL PB-E741-2 FOR MEDISONO P3 | In distribution | |
| PHASED ARRAY PROBE MODEL 3P-A FOR P10 PLUS | In distribution | |
| CONVEX ARRAY PROBE MODEL PB-C352UB FOR MEDISONO P10 & P10V (LONG CABLE) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hisense | Qingdao Hisense Medical Co., Ltd. | 219 |
| 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 |
| 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 |
|---|---|
| K231659 | 2024-02-15 |
| K170078 | 2017-05-17 |
| K163688 | 2017-02-23 |
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.