Product code IYO
- Product
- System, Imaging, Pulsed Echo, Ultrasonic
- Description
- Radiology Diagnostic Ultrasound Devices
- Regulation number
- 892.1560
- Radiation type
- Acoustic
- Applicable standards
- No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Current FDA Classification
- Device name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1560
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026-04-17 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025-08-01 |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | 2025-06-26 |
| 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 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025-04-23 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
| K241029 | SpineUs System | Verdure Imaging | 2024-10-07 |
| K233977 | Velacur | Sonic Incytes | 2024-09-04 |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | 2024-06-26 |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2024-06-12 |
| K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd | 2024-05-03 |
| K232302 | Pocket III | Quantel Medical | 2024-04-26 |
| K231677 | EdgeFlow UH10 | Edgecare, Inc. | 2024-03-06 |
| K240146 | BD Prevue II Peripheral Vascular Access System | Bard Access Systems, Inc. | 2024-02-18 |
| K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Eieling Technology Limited | 2024-02-12 |
| K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | 2023-12-29 |
| K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., Ltd. | 2023-12-21 |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 2023-12-21 |
| K230511 | K3900 Ultrasound Imaging System | Maui Imaging | 2023-10-25 |
| K232459 | Velacur | Sonic Incytes | 2023-09-12 |
| K231283 | SiteRite 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023-09-11 |
| K223448 | Bladder Scanner Model: BVT02 | Xuzhou Kaixin Electronic Instrument Co., Ltd. | 2023-07-07 |
| K223287 | Velacur | Sonic Incytes | 2023-04-20 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D510DUS6000 | ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM | ADVANCED INSTRUMENTATIONS, INC. | 2026-03-24 |
| 10841716103992 | ACIST HDi™ Cart | ACIST MEDICAL SYSTEMS, INC. | 2026-03-04 |
| 04987670102813 | DIAGNOSTIC ULTRASOUND SYSTEM | CANON INC. | 2026-03-01 |
| 06975345060108 | Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. | 2026-01-31 |
| 16978669290012 | Astrasono A5Pro Bladder Scanner | Astrasono technology co.,ltd. | 2026-01-15 |
| 20841436126346 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2025-12-31 |
| 00198953042816 | LOGIQ | Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc | 2025-12-05 |
| 00841517112141 | Sonosite MT | FUJIFILM SONOSITE, INC. | 2025-11-24 |
| 00841517112196 | Sonosite MT | FUJIFILM SONOSITE, INC. | 2025-11-24 |
| 16978669290005 | Astrasono A3Pro Bladder Scanner | Astrasono technology co.,ltd. | 2025-11-20 |
| 00198953001431 | Venue Go | Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc | 2025-11-17 |
| 00198953079256 | Vscan | GE Vingmed Ultrasound AS | 2025-11-17 |
| 00845225012984 | Patient Interface Module (PIMr) | Philips Image Guided Therapy Corporation | 2025-08-22 |
| 06971679948945 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co.,Ltd. | 2025-08-05 |
| 00198953001073 | Venue | Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc | 2025-07-31 |
| 00198953001097 | Venue Go | Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc | 2025-07-31 |
| 06938396401047 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396401054 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396401030 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396400484 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396400965 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396400972 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396400989 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396400996 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396401016 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 06938396401023 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-07-21 |
| 10855683006576 | Delphinus Sequr™ | PARKER LABORATORIES INC | 2023-01-24 |
| 00840682147118 | LOGIQ | GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC | 2020-05-26 |
| 08056304452658 | MyLab 9 eXP | ESAOTE SPA | 2018-02-19 |
| 08056304450296 | MyLabSix CrystallLine | ESAOTE SPA | 2016-11-29 |