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FDA 510(k)

NEUTRON THERAPY SYSTEM

K-Number: K063691 · 2007-01-31

ApplicantNorthern Illinois Univ. Outreach
Decision Date2007-01-31
Product CodeIWL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEUTRON THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Northern Illinois Univ. Outreach. It received FDA 510(k) clearance on 2007-01-31 under 510(k) number K063691. 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 NEUTRON THERAPY SYSTEM?

NEUTRON THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Northern Illinois Univ. Outreach. The 510(k) number is K063691.

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

NEUTRON THERAPY SYSTEM received FDA 510(k) clearance on 2007-01-31, under 510(k) number K063691.

Who is the listed applicant for NEUTRON THERAPY SYSTEM?

The FDA 510(k) record lists Northern Illinois Univ. Outreach as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUTRON THERAPY SYSTEM?

The FDA product code for NEUTRON THERAPY SYSTEM is IWL.

Related Clinical Trials

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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.

K852804MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYSMedcyc. Corp.K812337ISOCENTRIC NEUTRON THERAPY SYSTEMSThe Cyclotron Corp.K811778MODEL 4100 14 MEV NEUTRON GEN. THERAPYThe Cyclotron Corp.

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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