10 devices · 2 companies · 2018 to 2026
Subtle Medical, Inc.: AI-enabled devices on FDA's list
10 devices from Subtle Medical, Inc., 2018 to 2026, 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 (10 of 10 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Subtle Medical, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| SubtleHD-CTK254120 · 510(k) | Radiology | QIH | database entry | |
| SubtleHD-PETK254013 · 510(k) | Radiology | LLZ | database entry | |
| SubtleHDK243250 · 510(k) | Radiology | QIH | database entry | |
| AiMIFYK240290 · 510(k) | Radiology | LLZ | database entry | |
| SubtleSYNTHK241329 · 510(k) | Radiology | QIH | database entry | |
| SubtleMRK223623 · 510(k) | Radiology | LLZ | database entry | |
| SubtlePETK211964 · 510(k) | Radiology | KPS | database entry | |
| SubtleMRK203182 · 510(k) | Radiology | LLZ | database entry | |
| SubtleMRK191688 · 510(k) | Radiology | LLZ | database entry | |
| SubtlePETK182336 · 510(k) | Radiology | KPS | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.