Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
FDA 510(k) K192377 · Varian Medical Systems, Inc.
510(k) numberK192377
Submission
- Device name
- Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- August 30, 2019
- Decision date
- February 10, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 01/21/2026SE |
More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 08/03/2026SE |
| K261306 | AI Contouring (VA10A)QKB · Traditional | 07/10/2026SE |
| K260750 | Virtual Cone (1.0)MUJ · Traditional | 07/08/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | 06/04/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | 05/20/2026SE |
| K252815 | ProBeam 360 Proton Therapy System v3.0LHN · Traditional | 04/23/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | 03/18/2026SE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | 01/21/2026SE |
| K252919 | Identify (5.0)IYE · Traditional | 12/16/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | 11/19/2025SE |
Questions and answers
When was Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon cleared by the FDA?
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon (K192377) received a 510(k) decision of Substantially Equivalent on February 10, 2020, 164 days after the submission was received.
What is the product code of K192377?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.