12 devices · 10 companies · 2017 to 2026
Product code IYO: System, Imaging, Pulsed Echo, Ultrasonic
12 devices under product code IYO, 2017 to 2026, from 10 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (11 of 12 here), the regulation, and MAUDE report counts by product code.
System, Imaging, Pulsed Echo, Ultrasonic. 21 CFR 892.1560, Class II. MAUDE held 6,627 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| ARTHURK260190 · 510(k) | ROPCA ApS | Radiology | database entry | |
| EdgeFlow UW20K252237 · 510(k) | Edgecare, Inc. | Radiology | database entry | |
| QT Scanner 2000 Model AK253898 · 510(k) | QT Imaging Holdings, Inc. | Radiology | database entry | |
| Accuro 3SK243937 · 510(k) | Rivanna Medical, Inc. | Radiology | database entry | |
| SpineUs SystemK241029 · 510(k) | Verdure Imaging | Radiology | database entry | |
| VelacurK233977 · 510(k) | Sonic Incytes | Radiology | database entry | |
| EdgeFlow UH10K231677 · 510(k) | Edgecare Inc. | Radiology | database entry | |
| VelacurK223287 · 510(k) | Sonic Incytes | Radiology | database entry | |
| Butterfly iQ/iQ+ Ultrasound SystemK220068 · 510(k) | Butterfly Network, Inc. | Radiology | database entry | |
| Auto 3D Bladder Volume ToolK200980 · 510(k) | Butterfly Network, Inc. | Radiology | database entry | |
| UscanK181574 · 510(k) | EchoNous, Inc. | Radiology | database entry | |
| BladderScan Prime PLUS SystemK172356 · 510(k) | Verathon Incorporated | Radiology | database entry |
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