IYN · System, Imaging, Pulsed Doppler, Ultrasonic
Radiology · 21 CFR 892.1550 · Class 2
Overview
| Product Code | IYN |
|---|---|
| Device Name | System, Imaging, Pulsed Doppler, Ultrasonic |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 1159)
Showing 20 most recent of 1159 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.p.A. | Apr 6, 2026 | SESE |
| K252709 | Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Apr 2, 2026 | SESE |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Mar 27, 2026 | SESE |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Mar 27, 2026 | SESE |
| K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | Mar 27, 2026 | SESE |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | GE Medical Systems Ultrasound and Primary Care Diagnostics | Mar 24, 2026 | SESE |
| K252433 | Sonio Detect (v3) | Sonio | Mar 16, 2026 | SESE |
| K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | Mar 10, 2026 | SESE |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Feb 11, 2026 | SESE |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | Jan 20, 2026 | SESE |
| K253370 | LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics | Jan 8, 2026 | SESE |
| K253366 | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics | Jan 7, 2026 | SESE |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Jan 5, 2026 | SESE |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Edan Instruments, Inc. | Dec 23, 2025 | SESE |
| K252557 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | Dec 22, 2025 | SESE |
| K250959 | BioticsAI | Bioticsai, Inc. | Dec 22, 2025 | SESE |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) | Sonoscape Medical Corp. | Dec 5, 2025 | SESE |
| K250791 | ASUS Ultrasound Imaging System (LU800 series) | Asustek Computer, Inc. | Dec 4, 2025 | SESE |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Dec 3, 2025 | SESE |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) | Esaote, S.p.A. | Nov 25, 2025 | SESE |
Top Applicants
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — 82 clearances
- Siemens Medical Solutions USA, Inc. — 74 clearances
- Samsung Medison Co., Ltd. — 67 clearances
- GE Medical Systems Ultrasound and Primary Care Diagnostics — 57 clearances
- GE Healthcare — 52 clearances
