Product code IYO
- 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
- Source
- FDA openFDA device classification dataset
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 |
|---|---|---|---|
| 00850050934240 | EndoSound® EVS SideBeam 5103 | Endosound, Inc. | 2026-06-01 |
| 00850050934257 | EndoSound® Coax Transducer Extension Connector (TEC) | Endosound, Inc. | 2026-06-01 |
| 00850050934264 | EndoSound® EVS SideBeam 5105 (4 pouches) | Endosound, Inc. | 2026-06-01 |
| 04987670105937 | DIAGNOSTIC ULTRASOUND SYSTEM | CANON INC. | 2026-06-01 |
| 04987670106194 | DIAGNOSTIC ULTRASOUND SYSTEM | CANON INC. | 2026-06-01 |
| 08800013510112 | L8-17H | Alpinion Medical Systems Co., Ltd. | 2026-05-29 |
| 00198953121382 | Voluson | GE Ultrasound Korea Ltd. | 2026-05-28 |
| 04573596212318 | S3ESCLS | FUJIFILM CORPORATION | 2024-01-25 |
| 04573596212325 | S3ESEL | FUJIFILM CORPORATION | 2021-07-18 |
| 08052461860046 | Echolight S.p.a. | ECHOLIGHT SPA | 2021-03-05 |
| 00863686000302 | Breast Volume Navigator (BVN) | Metritrack, Inc. | 2017-05-01 |
| 08056304450500 | MyLabOne Vascular | Esaote Europe B.V. | 2016-09-27 |
| 08056304450494 | MyLabOne Musculoskeletal | Esaote Europe B.V. | 2016-09-27 |
| 08056304450487 | MyLabSat | Esaote Europe B.V. | 2016-09-27 |
| 08056304450470 | MyLabOne reg. Anestesia | Esaote Europe B.V. | 2016-09-27 |
| 08056304450432 | MyLabSix | Esaote Europe B.V. | 2016-09-27 |
| 08056304450425 | MyLab40 Basic Unit | Esaote Europe B.V. | 2016-09-27 |
| 08056304450401 | MyLab20 Plus | Esaote Europe B.V. | 2016-09-27 |
| 08056304450395 | MyLab40 | Esaote Europe B.V. | 2016-09-27 |
| 08056304450388 | MyLab40 eHD | Esaote Europe B.V. | 2016-09-27 |
| 08056304450364 | MyLabGamma | ESAOTE SPA | 2016-09-27 |
| 08056304450340 | "MyLabSeven LCD 19""" | ESAOTE SPA | 2016-09-27 |
| 08056304450333 | MyLabSeven | ESAOTE SPA | 2016-09-27 |
| 08056304450319 | MyLabClass C | ESAOTE SPA | 2016-09-27 |
| 08056304450302 | MyLabClass C Advanced | ESAOTE SPA | 2016-09-27 |
| 08056304450241 | MyLabFive BASIC UNIT | Esaote Europe B.V. | 2016-09-27 |
| 08056304450227 | MyLabFive | Esaote Europe B.V. | 2016-09-27 |
| 08056304450043 | MyLabSat USA | Esaote Europe B.V. | 2016-09-27 |
| 08056304450012 | MyLabAlpha | ESAOTE SPA | 2016-09-27 |
| 08056304450005 | MyLabTwice | ESAOTE SPA | 2016-09-27 |