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FDA 510(k)

TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER

K-Number: K112776 · 2011-12-22

ApplicantTomotherapy Incorporated
Decision Date2011-12-22
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER is the device name listed in this FDA 510(k) record. The listed applicant is Tomotherapy Incorporated. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K112776. 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 TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER?

TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Tomotherapy Incorporated. The 510(k) number is K112776.

When did TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER receive FDA 510(k) clearance?

TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER received FDA 510(k) clearance on 2011-12-22, under 510(k) number K112776.

Who is the listed applicant for TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER?

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 TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER?

The FDA product code for TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER 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.

K112446TOMOTHERAPY TREATMENT SYSTEMK082005MODIFICATION TO HI-ART TREATMENT SYSTEMK060912MODIFICATION TO: HI-ART SYSTEMK042739HI-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

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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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