Cleared Traditional

K021338 - ACCULEAF

K021338 is an FDA 510(k) clearance for ACCULEAF, manufactured by Direx Systems Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K021338 · Direx Systems Corp. · Radiology device
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Jan 2003
Decision
256d
Days
Class 2
Risk

K021338 is an FDA 510(k) clearance for the ACCULEAF. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Direx Systems Corp. (Natick, US). The FDA issued a Cleared decision on January 7, 2003 after a review of 256 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Direx Systems Corp. devices

FDA 510(k) Submission Details - K021338

510(k) Number K021338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date January 07, 2003
Days to Decision 256 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 107d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 328
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