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Modification to Hi-Art Treatment System

by Tomotherapy Incorporated

510(k) K082005

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082005 Date25 Aug 2008ClearedStatusActive

Recalls

7 recalls · FDA

    • Terminated Z-3108-2011 FDA Unclassified (pre-2012) initiated 13 Jul 2011

    As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occu

    • Terminated Z-3163-2011 FDA Unclassified (pre-2012) initiated 7 Jul 2011

    TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the TomoMobile Hi-Art System. TomoTherapy has discovered that when attempting to open the TomoMobile shielding doors, while the door hinges are in the locked position, the hinges may fail allowing the door to disengage from the shielding.

    • Terminated Z-1649-2011 FDA Unclassified (pre-2012) initiated 26 Jan 2011

    It was determined that the Treatment Planning Station (TPS) can potentially under dose.

    • Terminated Z-0814-2011 FDA Unclassified (pre-2012) initiated 8 Nov 2010

    TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure.

    • Terminated Z-2072-2010 FDA Unclassified (pre-2012) initiated 23 Jun 2010

    An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics.

    • Terminated Z-2115-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010

    In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.

    • Terminated Z-2219-2010 FDA Unclassified (pre-2012) initiated 1 Dec 2009

    An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station incorrectly rolls the image about

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUJ
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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