5 devices · 2 companies · 2024 to 2026
JLK, Inc.: AI-enabled devices on FDA's list
5 devices from JLK, Inc., 2024 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 JLK, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| JLK-NCCTK252421 · 510(k) | Radiology | QAS | database entry | |
| JLK-SDHK243611 · 510(k) | Radiology | QAS | database entry | |
| JLK-ICHK243363 · 510(k) | Radiology | QAS | database entry | |
| JBS-LVOK241480 · 510(k) | Radiology | QAS | database entry | |
| Medihub ProstateK233196 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.