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 1171)
Showing 20 most recent of 1171 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | May 27, 2026 | SESE |
| K260123 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | May 27, 2026 | SESE |
| K260398 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | May 26, 2026 | SESE |
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 | CHISON Medical Technologies Co., Ltd. | May 22, 2026 | SESE |
| K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | Wuhan United Imaging Healthcare Co.,Ltd | May 21, 2026 | SESE |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | Sonoscape Medical Corp. | May 15, 2026 | SESE |
| K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | Wuhan United Imaging Healthcare Co.,Ltd | May 15, 2026 | SESE |
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | May 14, 2026 | SESE |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | May 11, 2026 | SESE |
| K261132 | Healium Intelliscan LX192LC | Healium Intelliscan Corporation | May 5, 2026 | SESE |
| K252558 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | May 5, 2026 | SESE |
| K260589 | ES-Series | E-Scopics | Apr 29, 2026 | SESE |
| 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 |
Top Applicants
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — 83 clearances
- Siemens Medical Solutions USA, Inc. — 74 clearances
- Samsung Medison Co., Ltd. — 67 clearances
- GE Medical Systems Ultrasound and Primary Care Diagnostics — 58 clearances
- GE Healthcare — 52 clearances
