IYO — System, Imaging, Pulsed Echo, Ultrasonic Class II
FDA Device Classification
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 |
|---|
| K253898 | qt imaging holdings | QT Scanner 2000 Model A | March 4, 2026 |
| K253714 | philips image guided therapy corporation | IntraSight Plus | February 24, 2026 |
| K253221 | eieling technology (shenzhen) limited | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | February 6, 2026 |
| K250331 | astrasono technology co | Astrasono A3Pro Bladder Scanner (A3Pro) | September 30, 2025 |
| K250381 | deepsight technology | Deepsight NeedleVue LC1 Ultrasound System | August 1, 2025 |
| K243227 | accutome, inc. doing business as keeler usa | B-Scan | July 11, 2025 |
| K251728 | sonic incytes medical | Velacur One (LI-1100) | June 26, 2025 |
| K243880 | wuxi hisky medical technologies co | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini | June 17, 2025 |
| K243937 | rivanna medical | Accuro 3S | May 23, 2025 |
| K243479 | sonavex | EchoGuide (Version 1) | April 23, 2025 |
| K242496 | eieling technology (shenzhen) limited | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | November 19, 2024 |
| K241029 | verdure imaging | SpineUs System | October 7, 2024 |
| K233977 | sonic incytes | Velacur | September 4, 2024 |
| K233579 | fcu co | SC1 Handheld Ultrasound Imaging system (Model: SC1) | June 26, 2024 |
| K233613 | siemens medical solutions usa | ACUSON SC2000 Diagnostic Ultrasound System | June 12, 2024 |
| K232895 | contec medical systems co | B-Ultrasound Diagnostic System | May 3, 2024 |
| K232302 | quantel medical | Pocket III | April 26, 2024 |
| K231677 | edgecare | EdgeFlow UH10 | March 6, 2024 |
| K240146 | bard access systems | BD Prevue II Peripheral Vascular Access System | February 18, 2024 |
| K233401 | eieling technology limited | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | February 12, 2024 |