syngo.via RT Image Suite VC10
FDA 510(k) K252304 · Varian Medical Systems, Inc.
510(k) numberK252304
Submission
- Device name
- syngo.via RT Image Suite VC10
- Applicant
- Varian Medical Systems, Inc.
Palo Alto, CA, US - Received
- July 24, 2025
- Decision date
- March 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
| K252863 | ClearCalc Model RADCA V2.6MUJ · Traditional | Radformation, Inc. | 12/19/2025SE |
More from Radformation, 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 |
| 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 |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeamIYE · Traditional | 10/07/2025SE |
Questions and answers
When was syngo.via RT Image Suite VC10 cleared by the FDA?
syngo.via RT Image Suite VC10 (K252304) received a 510(k) decision of Substantially Equivalent on March 18, 2026, 237 days after the submission was received.
What is the product code of K252304?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.