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FDA 510(k)

MODIFICATION TO: HI-ART SYSTEM

K-Number: K033347 · 2003-11-12

ApplicantTomotherapy Incorporated
Decision Date2003-11-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: 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 2003-11-12 under 510(k) number K033347. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: HI-ART SYSTEM?

MODIFICATION TO: HI-ART SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is Tomotherapy Incorporated. The 510(k) number is K033347.

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

MODIFICATION TO: HI-ART SYSTEM received FDA 510(k) clearance on 2003-11-12, under 510(k) number K033347.

Who is the listed applicant for MODIFICATION TO: 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 MODIFICATION TO: HI-ART SYSTEM?

The FDA product code for MODIFICATION TO: HI-ART SYSTEM is IYE.

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 SYSTEMK042739HI-ART SYSTEM

Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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