Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
K232923Varian Medical Systems Inc. · cleared 2024-04-30 · product code IYE · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.6)
“Organs are detected on the patient image via artificial intelligence (Al) segmentation models. These models consist of convolutional neural networks, the weights of which are static.”
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.”
Validation studies (1)
Bench
n=1,045 scans
endpoints: DICE similarity coefficient; Models were only considered eligible for production if they consistently produced contours that needed minor or no adjustments in at least 80% of the test cases.
standards: FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, ISO 14971 Risk Management Standard, IEC 62304 Software Life Cycle Process standard
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
- 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.
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.
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).