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FDA 510(k)

ISOCENTRIC NEUTRON THERAPY SYSTEMS

K-Number: K812337 · 1981-10-02

ApplicantThe Cyclotron Corp.
Decision Date1981-10-02
Product CodeIWL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOCENTRIC NEUTRON THERAPY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is The Cyclotron Corp.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812337. The device is classified under product code IWL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOCENTRIC NEUTRON THERAPY SYSTEMS?

ISOCENTRIC NEUTRON THERAPY SYSTEMS is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is The Cyclotron Corp.. The 510(k) number is K812337.

When did ISOCENTRIC NEUTRON THERAPY SYSTEMS receive FDA 510(k) clearance?

ISOCENTRIC NEUTRON THERAPY SYSTEMS received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812337.

Who is the listed applicant for ISOCENTRIC NEUTRON THERAPY SYSTEMS?

The FDA 510(k) record lists The Cyclotron Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOCENTRIC NEUTRON THERAPY SYSTEMS?

The FDA product code for ISOCENTRIC NEUTRON THERAPY SYSTEMS is IWL.

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 The Cyclotron Corp. 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.

K811778MODEL 4100 14 MEV NEUTRON GEN. THERAPY

Related Devices (Code: IWL)

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.

K063691NEUTRON THERAPY SYSTEMNorthern Illinois Univ. OutreachK852804MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYSMedcyc. Corp.K811778MODEL 4100 14 MEV NEUTRON GEN. THERAPYThe Cyclotron Corp.

Official Source

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

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