Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)

K232923

Varian Medical Systems Inc. · cleared 2024-04-30 · product code IYE · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Ethos Treatment Management is a software product designed to help radiation therapy medical professionals manage treatments for patients with malignant or benign diseases for whom radiation therapy is indicated. Ethos Treatment Planning is a standalone software device designed to generate and modify radiation therapy treatment plans and manage treatment sessions.”
AlgorithmAI segmentation models consisting of convolutional neural networks
source quote (p.6)
“Organs are detected on the patient image via artificial intelligence (AI) segmentation models. These models consist of convolutional neural networks, the weights of which are static.”
Adaptive (vs locked)No
source quote (p.6)
“They are not adapted during the operation of the product. That means, the models do not continuously learn and thus do not alter their behavior over time based on user input.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

standards: 21 CFR §820, ISO 13485, ISO 14971, IEC 62304

Bench

n=1,045 scans

endpoints: DICE similarity coefficient; quality of the contours across test sets to assess the need and the type of contour adjustments; estimate of the time saved on contouring tasks

Reported performance (1 observation)

diceas written: “DICE similarity coefficient”stated without value
source quote (p.7)
“This initial stage relies on quantitative metrics such as the DICE similarity coefficient.”

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
9
drift signals on this device
  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYE (Zap Surgical Systems, initiated 2025-07-25): "If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automat" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97413

  • …and 3 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/K232923