IYO — System, Imaging, Pulsed Echo, Ultrasonic Class II
FDA product code IYO covers "System, Imaging, Pulsed Echo, Ultrasonic", a Class II medical device regulated under 21 CFR 892.1560. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IYO
- Device Class
- Class II
- Regulation Number
- 892.1560
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253452 | Rivanna Medical | Accuro 3S | Jul 24, 2026 |
| K260190 | Ropca Aps | ARTHUR | Jun 18, 2026 |
| K252237 | Edgecare | EdgeFlow UW20 | Apr 17, 2026 |
| K254021 | Rivanna Medical | Accuro XV | Apr 9, 2026 |
| K253898 | Qt Imaging Holdings | QT Scanner 2000 Model A | Mar 4, 2026 |
| K253714 | Philips Image Guided Therapy Corporation | IntraSight Plus | Feb 24, 2026 |
| K253221 | Eieling Technology (Shenzhen) Limited | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Feb 6, 2026 |
| K250331 | Astrasono Technology Co | Astrasono A3Pro Bladder Scanner (A3Pro) | Sep 30, 2025 |
| K250381 | Deepsight Technology | Deepsight NeedleVue LC1 Ultrasound System | Aug 1, 2025 |
| K243227 | Accutome, Inc. Doing Business As Keeler Usa | B-Scan | Jul 11, 2025 |
| K251728 | Sonic Incytes Medical | Velacur One (LI-1100) | Jun 26, 2025 |
| K243880 | Wuxi Hisky Medical Technologies Co | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini | Jun 17, 2025 |
| K243937 | Rivanna Medical | Accuro 3S | May 23, 2025 |
| K243479 | Sonavex | EchoGuide (Version 1) | Apr 23, 2025 |
| K242496 | Eieling Technology (Shenzhen) Limited | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Nov 19, 2024 |
| K241029 | Verdure Imaging | SpineUs System | Oct 7, 2024 |
| K233977 | Sonic Incytes | Velacur | Sep 4, 2024 |
| K233579 | Fcu Co | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Jun 26, 2024 |
| K233613 | Siemens Medical Solutions Usa | ACUSON SC2000 Diagnostic Ultrasound System | Jun 12, 2024 |
| K232895 | Contec Medical Systems Co | B-Ultrasound Diagnostic System | May 3, 2024 |