Radiology · 510(k) · 2020
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Varian Medical Systems, Inc.. Cleared by FDA on 10 February 2020 under submission K192377, product code IYE (accelerator, linear, medical). What FDA's record says, in FDA's words.
Device record · K192377
- Device. Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonDEVICE
- Company. Varian Medical Systems, Inc.COMPANY
- Decision. 10 February 2020, 510(k), substantially equivalent (traditional review); received 30 August 2019DECISION
- Panel. RadiologyPANEL
- Product code. IYE, Accelerator, Linear, MedicalCODE
- Regulation. 21 CFR 892.5050, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Ethos Treatment Management is indicated for use in managing and monitoring radiation therapy treatment plans and sessions. Ethos Treatment Planning is indicated for use in generating and modifying radiation therapy treatment plans. Halcyon and Ethos Radiotherapy System are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 3,077 reports filed against devices carrying product code IYE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
24 September 2026 · Malfunction · Elekta Synergy · Elekta Solutions AB · report 3015232217-2026-00033
The customer reported that they were not able to perform table shift movements during treatment. The table hight was stuck above standing height.
17 September 2026 · Malfunction · Elekta Medical Linear Accelerator (EMLA) · Elekta Solutions AB · report 3015232217-2026-00032
Elekta has internally identified braze overflow into the internal cavities of the waveguide cells in the manufacturing process for assembling of machined waveguide cells. This can lead to dark current on Elekta Medical Linear Accelerators.
14 September 2026 · Other · MOSAIQ · Elekta Solutions AB · report 3015232217-2026-00029
The customer reported that the Cone Beam Computed Tomography (CBCT) was taken. However, the system did not record the CBCT as having been completed.
3 September 2026 · Malfunction · Elekta Synergy · Elekta Solutions AB · report 3015232217-2026-00028
The customer reported that a fire developed in the modulator area.
28 August 2026 · Malfunction · Radixact Treatment Delivery System · Accuray Incorporated · report 3003873069-2026-00002
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code IYE, in Radiology, from Varian Medical Systems, Inc., or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.