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 |
|---|---|---|---|
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 |
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 |
| 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 |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 2023-12-21 |
| K232320 | iSR`obot Mona Lisa 2.0 | Biobot Surgical Pte., 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841436102797 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2023-05-08 |
| 00841436100526 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2018-08-17 |
| 00841436100533 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2018-08-17 |
| 00841436101110 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436105699 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436105682 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436105675 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436105668 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436105651 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436105583 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436103435 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436103428 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436103206 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436102636 | omniTRAX Patient Tracker Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436102063 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436101936 | VirtuTRAX Instrument Navigator | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436101844 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100274 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436101103 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436101073 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436101042 | omniTRAX Patient Tracker Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100892 | VirtuTRAX Instrument Navigator | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100885 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100519 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100342 | eTRAX™ Needle System Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100328 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100311 | Biopsy Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100304 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100298 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 00841436100281 | Tracking Bracket Starter Kit | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |