5 devices · 2 companies · 2021 to 2026
Airs Medical, Inc.: AI-enabled devices on FDA's list
5 devices from Airs Medical, Inc., 2021 to 2026, from 2 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Airs Medical, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| SwiftMRK253775 · 510(k) | Radiology | QIH | database entry | |
| SwiftSight-BrainK251483 · 510(k) | Radiology | QIH | database entry | |
| SwiftMRK230854 · 510(k) | Radiology | LLZ | database entry | |
| SwiftMRK220416 · 510(k) | Radiology | LLZ | database entry | |
| SwiftMRK210999 · 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.