FDA 510(k)

Eclipse Treatment Planning System (v18.0)

K-Number: K230557 · 2023-05-26

Decision Date2023-05-26

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Eclipse Treatment Planning System (v18.0) is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-05-26 under approval number K230557. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse Treatment Planning System (v18.0)?

Eclipse Treatment Planning System (v18.0) is a medical device that received FDA 510(k) clearance on 2023-05-26. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K230557.

When was Eclipse Treatment Planning System (v18.0) approved by the FDA?

Eclipse Treatment Planning System (v18.0) received FDA 510(k) clearance on 2023-05-26, under approval number K230557.

What company makes Eclipse Treatment Planning System (v18.0)?

Eclipse Treatment Planning System (v18.0) is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Eclipse Treatment Planning System (v18.0)?

The FDA product code for Eclipse Treatment Planning System (v18.0) is MUJ.

Related Clinical Trials

NCT07614997 Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck NOT_YET_RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41271017 Lymphedema Imaging and AI: A Review of Diagnostic Modalities, Biomarkers, and Clinical Integration. Biomedical journal (2025) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Other Devices by Varian Medical Systems, Inc.

K162476Varian High Energy Linear Accelerator K160045Heyman Packing Applicator Set K161540Advanced Breast Template System K161576Esophagus Bougie Set K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths K160021Varian Sterilization Boxes

View all 83 devices →

Related Devices (Code: MUJ)

K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. K161136Precision Treatment Planning SystemAccuray Incorporated K160093RayStationRaySearch Laboratories AB (PUBL) K151435MRCATPhilips Medical Systems MR Finland K153368Radiance V3Gmv Soluciones Globales Internet S.A.U. K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose ReviewBrainlab AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.