RayStation 11.0

Validation studies (2)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

• re_clearance

  The FDA AI/ML device list shows a newer 510(k) K240398 (decision 2025-04-04) from RaySearch Laboratories AB (PUBL) for a matching device line ("RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K240398

• re_clearance

  The FDA AI/ML device list shows a newer 510(k) K222312 (decision 2023-03-29) from RaySearch Laboratories AB (publ) for a matching device line ("RayStation 12A") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K222312

• re_clearance

  The FDA AI/ML device list shows a newer 510(k) K220141 (decision 2022-04-15) from RaySearch Laboratories AB (publ) for a matching device line ("RayStation 11B") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K220141

• recall_reason_pattern

  Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-08-05): "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:97049

• recall_reason_pattern

  Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17): "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ," Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:97309

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.