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FDA 510(k)

HI-ART SYSTEM

K-Number: K042739 · 2004-11-03

ApplicantTomotherapy Incorporated
Decision Date2004-11-03
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HI-ART SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tomotherapy Incorporated. It received FDA 510(k) clearance on 2004-11-03 under 510(k) number K042739. 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 HI-ART SYSTEM?

HI-ART SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-03. The listed applicant is Tomotherapy Incorporated. The 510(k) number is K042739.

When did HI-ART SYSTEM receive FDA 510(k) clearance?

HI-ART SYSTEM received FDA 510(k) clearance on 2004-11-03, under 510(k) number K042739.

Who is the listed applicant for HI-ART SYSTEM?

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

What is the FDA product code for HI-ART SYSTEM?

The FDA product code for HI-ART SYSTEM is MUJ.

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.

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Other records listing Tomotherapy Incorporated 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.

K112776TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZERK112446TOMOTHERAPY TREATMENT SYSTEMK082005MODIFICATION TO HI-ART TREATMENT SYSTEMK060912MODIFICATION TO: HI-ART SYSTEMK033347MODIFICATION TO: HI-ART SYSTEM

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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