Radiation_oncology
RayStation Deep Learning Segmentation
RaySearch Laboratories
FDACE
FDA-cleared AI medical device
AI contouring module inside the RayStation treatment-planning system that auto-segments organs-at-risk across more than 50 anatomical sites.
FDA Submission Metadata
- Submission number
- K200569
- Decision date
- September 2020
- FDA panel
- Radiology
- Product code
- MUJ
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA
US FDA 510k
CE
EU CE MDR