Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

Validation studies (1)

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) K232923 (decision 2024-04-30) from Varian Medical Systems Inc. for a matching device line ("Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K232923

• recall_reason_pattern

  Software/algorithm-related recall in product code IYE (Accuray Incorporated, initiated 2026-06-16): "In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:99075

• recall_reason_pattern

  Software/algorithm-related recall in product code IYE (Accuray Incorporated, initiated 2026-06-16): "In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:99083

• recall_reason_pattern

  Software/algorithm-related recall in product code IYE (Elekta, Inc., initiated 2026-05-21): "Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs." Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98980

• recall_reason_pattern

  Software/algorithm-related recall in product code IYE (Elekta, Inc., initiated 2025-12-10): "Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or l" Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:98116

• recall_reason_pattern

  Software/algorithm-related recall in product code IYE (ELEKTA SOLUTIONS AB, initiated 2025-09-17): "When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule." Recalling firm is another firm in the same product code.

  first seen 2026-07-08 · recall res_event_number:97562

• …and 4 more.

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.