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

FDA 510(k)

Real Time Image Gating System for Proton Beam Therapy Systems

K-Number: K171049 · 2017-12-26

ApplicantHitachi, Ltd. Healthcare
Decision Date2017-12-26
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Real Time Image Gating System for Proton Beam Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Healthcare. It received FDA 510(k) clearance on 2017-12-26 under 510(k) number K171049. 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 Real Time Image Gating System for Proton Beam Therapy Systems?

Real Time Image Gating System for Proton Beam Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-12-26. The listed applicant is Hitachi, Ltd. Healthcare. The 510(k) number is K171049.

When did Real Time Image Gating System for Proton Beam Therapy Systems receive FDA 510(k) clearance?

Real Time Image Gating System for Proton Beam Therapy Systems received FDA 510(k) clearance on 2017-12-26, under 510(k) number K171049.

Who is the listed applicant for Real Time Image Gating System for Proton Beam Therapy Systems?

The FDA 510(k) record lists Hitachi, Ltd. Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems?

The FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems is LHN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06708221A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy MethodsNOT_YET_RECRUITINGNCT06465966UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam ScanningRECRUITING

Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.

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.

↑