8 devices · 2 companies · 2022 to 2025
Pearl, Inc.: AI-enabled devices on FDA's list
8 devices from Pearl, Inc., 2022 to 2025, 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 (8 of 8 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Pearl, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Second Opinion PanoramicK250525 · 510(k) | Radiology | MYN | database entry | |
| Second Opinion CSK243234 · 510(k) | Radiology | MYN | database entry | |
| Second Opinion 3DK243989 · 510(k) | Radiology | QIH | database entry | |
| Second Opinion BLEK243230 · 510(k) | Radiology | QIH | database entry | |
| Second Opinion PediatricK243893 · 510(k) | Radiology | MYN | database entry | |
| Second Opinion Periapical Radiolucency ContoursK242600 · 510(k) | Radiology | MYN | database entry | |
| Second Opinion CCK242522 · 510(k) | Radiology | MYN | database entry | |
| Second OpinionK210365 · 510(k) | Radiology | MYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.