FDA Product Code
FDA Product Code IYO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1560
510(k) Clearances — 895 records · page 1 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | 2026-09-24 | Traditional | PDF ↗ |
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 | Traditional | PDF ↗ |
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 | Traditional | PDF ↗ |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026-04-17 | Traditional | PDF ↗ |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 | Traditional | PDF ↗ |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 | Special | PDF ↗ |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 | Traditional | PDF ↗ |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | 2026-02-06 | Traditional | PDF ↗ |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025-09-30 | Traditional | PDF ↗ |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025-08-01 | Traditional | PDF ↗ |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 | Traditional | PDF ↗ |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | 2025-06-26 | Special | PDF ↗ |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 | Traditional | PDF ↗ |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 | Traditional | PDF ↗ |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025-04-23 | Traditional | PDF ↗ |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | 2024-11-19 | Traditional | PDF ↗ |
| K241029 | SpineUs System | Verdure Imaging | 2024-10-07 | Traditional | PDF ↗ |
| K233977 | Velacur | Sonic Incytes | 2024-09-04 | Traditional | PDF ↗ |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | 2024-06-26 | Special | PDF ↗ |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-06-12 | Special | PDF ↗ |
| K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2024-05-03 | Traditional | PDF ↗ |
| K232302 | Pocket III | Quantel Medical | 2024-04-26 | Traditional | PDF ↗ |
| K231677 | EdgeFlow UH10 | Edgecare, Inc. | 2024-03-06 | Traditional | PDF ↗ |
| K240146 | BD Prevue II Peripheral Vascular Access System | Bard Access Systems, Inc. | 2024-02-18 | Special | PDF ↗ |
| K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited | 2024-02-12 | Traditional | PDF ↗ |
| K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | 2023-12-29 | Traditional | PDF ↗ |
| K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023-12-21 | Special | PDF ↗ |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 2023-12-21 | Traditional | PDF ↗ |
| K230511 | K3900 Ultrasound Imaging System | Maui Imaging | 2023-10-25 | Traditional | PDF ↗ |
| K232459 | Velacur | Sonic Incytes | 2023-09-12 | Special | PDF ↗ |
| K231283 | SiteRite 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023-09-11 | Traditional | PDF ↗ |
| K223448 | Bladder Scanner Model: BVT02 | Xuzhou Kaixin Electronic Instrument Co., Ltd. | 2023-07-07 | Traditional | PDF ↗ |
| K223287 | Velacur | Sonic Incytes | 2023-04-20 | Traditional | PDF ↗ |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | 2023-03-31 | Traditional | PDF ↗ |
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | Echosens | 2023-03-02 | Traditional | PDF ↗ |
| K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2023-01-09 | Traditional | PDF ↗ |
| K220933 | QT Scanner 2000 Model A | Qt Imaging, Inc. | 2022-08-31 | Traditional | PDF ↗ |
| K213488 | Bladder Scanner, Model Name:M5 | Suzhou Peaksonic Medical Technology Co., Ltd. | 2022-07-01 | Traditional | PDF ↗ |
| K211529 | NAVIRFA Scope | Navifus Corporation | 2022-05-05 | Traditional | PDF ↗ |
| K213620 | ATUSA Automated 3D Breast Ultrasound System | Isono Health, Inc. | 2022-04-22 | Traditional | PDF ↗ |
| K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022-03-16 | Traditional | PDF ↗ |
| K213411 | iSRobot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2021-12-22 | Traditional | PDF ↗ |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 | Infraredx, Inc. | 2021-12-07 | Traditional | PDF ↗ |
| K213070 | MD-320W Ultrasound Biomicroscope | MEDA Co., Ltd. | 2021-11-18 | Traditional | PDF ↗ |
| K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | 2021-11-15 | Traditional | PDF ↗ |
| K211726 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2021-11-05 | Traditional | PDF ↗ |
| K212035 | FibroScan 230 | Echosens | 2021-07-30 | Special | PDF ↗ |
| K210468 | SC1 Handheld Ultrasound Imaging System (Model: SC1) | Fcu Co., Ltd. | 2021-07-23 | Traditional | PDF ↗ |
| K203659 | iSR'obot Mona Lisa 1.0 | Biobot Surgical Pte., Ltd. | 2021-07-08 | Traditional | PDF ↗ |
| K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021-06-25 | Traditional | PDF ↗ |
| K211623 | THD Procto Software System | Thd Spa | 2021-06-24 | Special | PDF ↗ |
| K210591 | Palm Bladder Scanner - PBSV7.1 | Mianyang Meike Electronic Equipment Co., Ltd. | 2021-06-09 | Special | PDF ↗ |
| K211098 | Breast Volume Navigator (BVN) Model G-2000 | Metritrack, Inc. | 2021-05-26 | Traditional | PDF ↗ |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | Echosens | 2021-03-25 | Traditional | PDF ↗ |
| K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2021-02-26 | Traditional | PDF ↗ |
| K203719 | IntraSight Mobile | Volcano Corporation | 2021-01-19 | Special | PDF ↗ |
| K202119 | AcuSee AS-P1000 System | Weipeng (Suzhou) Medical Devices Co., Ltd. | 2020-10-07 | Traditional | PDF ↗ |
| K201995 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | 2020-08-19 | Special | PDF ↗ |
| K201597 | Liver Incytes, Model 1005 | Sonic Incytes | 2020-07-31 | Traditional | PDF ↗ |
| K200655 | FibroScan® 630 | Echosens | 2020-07-16 | Traditional | PDF ↗ |
| K200980 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | 2020-06-11 | Traditional | PDF ↗ |
| K200749 | CUBEScan BioCon-900S | Mcube Technology Co., Ltd. | 2020-05-19 | Traditional | PDF ↗ |
| K200548 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | 2020-03-27 | Traditional | PDF ↗ |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | 2020-03-17 | Traditional | PDF ↗ |
| K192253 | SonicEye Dual-Array Ultrasound System | Sonivate Medical, Inc. | 2020-02-25 | Traditional | PDF ↗ |
| K193512 | THD Procto Software System | Thd Spa | 2020-01-26 | Traditional | PDF ↗ |
| K192170 | VistaScan USB Ultrasound Imaging System | Emagine Solutions Technology, LLC | 2020-01-23 | Traditional | PDF ↗ |
| K192791 | Diagnostic Ultrasound System | Edan Instruments, Inc. | 2019-11-27 | Traditional | PDF ↗ |
| K192573 | Dolphin Medical Imaging USB Ultrasound System | Dolphin Medical Imaging, LLC | 2019-11-19 | Traditional | PDF ↗ |
| K190646 | QT Scanner 2000 Model A | Qt Ultrasound, LLC | 2019-10-18 | Traditional | PDF ↗ |
| K190314 | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | Mednovel Technology, Ltd. | 2019-10-09 | Traditional | PDF ↗ |
| K191541 | Vave Personal Ultrasound System | Vave Health, Inc. | 2019-07-10 | Traditional | PDF ↗ |
| K183173 | LIGHTMED Ultrasound System | Lightmed USA, Inc. | 2019-07-01 | Traditional | PDF ↗ |
| K191307 | Palm Bladder Scanner - PBSV5.1 | Mianyang Meike Electronic Equipment Co., Ltd. | 2019-06-05 | Special | PDF ↗ |
| K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W) | Suzhou Lischka Medtech Co., Ltd. | 2019-05-22 | Traditional | PDF ↗ |
| K182460 | MD-6000P Bladder Scanner | MEDA Co., Ltd. | 2019-05-06 | Traditional | PDF ↗ |
| K190786 | Eye Prime | Ellex Medical Pty, Ltd. | 2019-04-11 | Traditional | PDF ↗ |
| K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2019-03-28 | Traditional | PDF ↗ |
| K183414 | ABSOLU | Quantel Medical | 2019-03-20 | Traditional | PDF ↗ |
| K190039 | EchoSure Diagnostic Ultrasound System | Sonavex, Inc. | 2019-03-08 | Traditional | PDF ↗ |
| K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech | C. R. Bard | 2018-10-24 | Traditional | PDF ↗ |
| K182213 | QT Ultrasound Breast Scanner - 1 | Qt Ultrasound, LLC | 2018-09-14 | Special | PDF ↗ |
| K182153 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2018-09-06 | Special | PDF ↗ |
| K181574 | Uscan | EchoNous, Inc. | 2018-07-10 | Traditional | PDF ↗ |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2018-07-09 | Special | PDF ↗ |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | 2018-06-22 | Traditional | PDF ↗ |
| K180636 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging, Inc. | 2018-04-30 | Traditional | PDF ↗ |
| K170761 | LIGHTSonic BUBM | Lightmed USA, Inc. | 2018-04-13 | Traditional | PDF ↗ |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System | Volcano Corporation | 2018-04-11 | Traditional | PDF ↗ |
| K172256 | SoftVue | Delphinus Medical Technologies | 2018-03-02 | Traditional | PDF ↗ |
| K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | 2018-03-02 | Traditional | PDF ↗ |
| K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | Guangzhou Sonostar Technologies Co., Ltd. | 2018-02-28 | Abbreviated | PDF ↗ |
| K180084 | Ultrasound System SONIMAGE MX1 | Konica Minolta, Inc. | 2018-02-08 | Traditional | PDF ↗ |
| K171528 | Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) | Avantsonic Technology Co., Ltd. | 2018-01-24 | Traditional | PDF ↗ |
| K172056 | InnoSight Diagnostic Ultrasound System | Qisda Corporation | 2017-12-13 | Traditional | PDF ↗ |
| K170046 | Lilium a-200E | Lilium Otsuka Co., Ltd. | 2017-12-07 | Traditional | PDF ↗ |
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging System | Advanced Instrumentations, Inc. | 2017-12-01 | Abbreviated | PDF ↗ |
| K170856 | CMS600P2 B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2017-11-17 | Traditional | PDF ↗ |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2017-11-14 | Traditional | PDF ↗ |
| K173138 | Biim Diagnostic Ultrasound System | Biim Ultrasound AS | 2017-10-27 | Traditional | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.