4 devices · 1 company · 2023 to 2025
Disior Ltd: AI-enabled devices on FDA's list
4 devices from Disior Ltd, 2023 to 2025, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Disior Ltd
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| SMART PCFDK250023 · 510(k) | Radiology | QIH | database entry | |
| SMART Bun-Yo-Matic X-RayK240736 · 510(k) | Radiology | QIH | database entry | |
| SMART Bun-Yo-Matic CTK240642 · 510(k) | Radiology | QIH | database entry | |
| BonelogicK223757 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.