Cleared Special

K033347 - MODIFICATION TO: HI-ART SYSTEM

K033347 is an FDA 510(k) clearance for MODIFICATION TO: HI-ART SYSTEM, manufactured by Tomotherapy Incorporated. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 23-day FDA review.

K033347 · Tomotherapy Incorporated · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2003
Decision
23d
Days
Class 2
Risk

K033347 is an FDA 510(k) clearance for the MODIFICATION TO: HI-ART SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Tomotherapy Incorporated (Madison, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tomotherapy Incorporated devices

FDA 510(k) Submission Details - K033347

510(k) Number K033347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2003
Decision Date November 12, 2003
Days to Decision 23 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 371
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