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FDA 510(k)

PROTON THERAPY SYSTEM

K-Number: K983024 · 2001-07-12

ApplicantIon Beam Applications S.A.
Decision Date2001-07-12
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROTON THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ion Beam Applications S.A.. It received FDA 510(k) clearance on 2001-07-12 under 510(k) number K983024. 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 PROTON THERAPY SYSTEM?

PROTON THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-12. The listed applicant is Ion Beam Applications S.A.. The 510(k) number is K983024.

When did PROTON THERAPY SYSTEM receive FDA 510(k) clearance?

PROTON THERAPY SYSTEM received FDA 510(k) clearance on 2001-07-12, under 510(k) number K983024.

Who is the listed applicant for PROTON THERAPY SYSTEM?

The FDA 510(k) record lists Ion Beam Applications S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTON THERAPY SYSTEM?

The FDA product code for PROTON THERAPY SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ion Beam Applications S.A. as applicant

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.

K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)K132847I2CK101508MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235K100766IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235K092796IBA PROTON THERAPY SYSTEM, PROTEUS 235K091629PROTEUS 235 PROTON THERAPY SYSTEM

View all 12 devices →

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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-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.

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.

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