Radiology
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
RaySearch Laboratories AB (PUBL)
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K240398
- Decision date
- April 2025
- FDA panel
- Radiology
- Product code
- MUJ
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.