Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ProNova SC360 Proton Therapy System

K-Number: K162246 · 2016-12-08

ApplicantPronova Solutions, LLC
Decision Date2016-12-08
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProNova SC360 Proton Therapy System is a medical device manufactured by Pronova Solutions, LLC. It received FDA 510(k) clearance on 2016-12-08 under approval number K162246. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProNova SC360 Proton Therapy System?

ProNova SC360 Proton Therapy System is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Pronova Solutions, LLC. The 510(k) number is K162246.

When was ProNova SC360 Proton Therapy System approved by the FDA?

ProNova SC360 Proton Therapy System received FDA 510(k) clearance on 2016-12-08, under approval number K162246.

What company makes ProNova SC360 Proton Therapy System?

ProNova SC360 Proton Therapy System is manufactured by Pronova Solutions, LLC.

What is the FDA product code for ProNova SC360 Proton Therapy System?

The FDA product code for ProNova SC360 Proton Therapy System is LHN.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING 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 NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Related Devices (Code: LHN)

K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi , Ltd. K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company K160063McLaren Proton Therapy SystemMclaren Health Care Corporation

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.

↑