Cleared Special

K021463 - MODEL 1133 IVD PC VERSION

K021463 is an FDA 510(k) clearance for MODEL 1133 IVD PC VERSION, manufactured by Sun Nuclear Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 30-day FDA review.

K021463 · Sun Nuclear Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
30d
Days
Class 2
Risk

K021463 is an FDA 510(k) clearance for the MODEL 1133 IVD PC VERSION. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Sun Nuclear Corp. (Melbourne, US). The FDA issued a Cleared decision on June 6, 2002 after a review of 30 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 Sun Nuclear Corp. devices

FDA 510(k) Submission Details - K021463

510(k) Number K021463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2002
Decision Date June 06, 2002
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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

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