4 devices · 2 companies · 2018 to 2023
Healthy.io Ltd.: AI-enabled devices on FDA's list
4 devices from Healthy.io Ltd., 2018 to 2023, from 2 companies across 3 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 Healthy.io Ltd.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Minuteful-kidney testK222921 · 510(k) | Clinical Chemistry | JIR | database entry | |
| Minuteful - kidney testK210069 · 510(k) | Clinical Chemistry | JIR | database entry | |
| ACR LAB Urine Analysis Test SystemK182384 · 510(k) | Clinical Chemistry | JFY | database entry | |
| DIP/U.S. Urine Analysis Test SystemK173327 · 510(k) | Clinical Chemistry | JIL | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.