8 devices · 2 companies · 2019 to 2025
RaySearch Laboratories AB (PUBL): AI-enabled devices on FDA's list
8 devices from RaySearch Laboratories AB (PUBL), 2019 to 2025, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 8 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| RayStation 2023B, RayPlan 2023B, RayStation 2024K240398 · 510(k) | Radiology | MUJ | database entry | |
| RayStation 12AK222312 · 510(k) | Radiology | MUJ | database entry | |
| RayStation 11BK220141 · 510(k) | Radiology | MUJ | database entry | |
| RayStation 11.0K211867 · 510(k) | Radiology | MUJ | database entry | |
| RayStation 10.1K210645 · 510(k) | Radiology | MUJ | database entry | |
| RayStationK200569 · 510(k) | Radiology | MUJ | database entry | |
| RayCare 2.3K191384 · 510(k) | Radiology | MUJ | database entry | |
| RayStationK190387 · 510(k) | Radiology | MUJ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.