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FDA 510(k)

HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM

K-Number: K010682 · 2001-06-05

ApplicantMds Nordion
Decision Date2001-06-05
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mds Nordion. It received FDA 510(k) clearance on 2001-06-05 under 510(k) number K010682. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM?

HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-05. The listed applicant is Mds Nordion. The 510(k) number is K010682.

When did HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM receive FDA 510(k) clearance?

HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM received FDA 510(k) clearance on 2001-06-05, under 510(k) number K010682.

Who is the listed applicant for HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM?

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

What is the FDA product code for HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM?

The FDA product code for HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM is MUJ.

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Other records listing Mds Nordion as applicant

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Related Devices (Code: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, 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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