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

K192377

Varian Medical Systems, Inc. · cleared 2020-02-10 · product code IYE · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.1)
“Medical charged-particle radiation therapy system”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: ISO 13485, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 61217, IEC 62274, IEC 62083, IEC 82304-1, IEC 62366-1, IEC 60825-1, IEC 60976, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-1, IEC 60601-2-68, ISO 15223-1

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.

Predicate network

Postmarket — what happened after clearance

13
recalls in product code, 24mo
48
MAUDE reports in code, 12mo
-54%
vs code's own 3-yr baseline
10
drift signals on this device
  • 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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland) — same firm and product code, not necessarily this device · initiated 2022-03-21

    Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

    recall event 89922 (openFDA)

  • Recalling firm matches this device's applicant (Varian Medical Systems, Inc.) — same firm and product code, not necessarily this device · initiated 2019-08-12

    After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.

    recall event 85269 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K192377