Cleared Traditional

K930279 - REFIX(TM) SYSTEM

K930279 is an FDA 510(k) clearance for REFIX(TM) SYSTEM, manufactured by Nomos Corp.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K930279 · Nomos Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
187d
Days
Class 2
Risk

K930279 is an FDA 510(k) clearance for the REFIX(TM) SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Nomos Corp. (South Miami, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 187 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.

FDA 510(k) Submission Details - K930279

510(k) Number K930279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date July 27, 1993
Days to Decision 187 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 107d · This submission: 187d
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 676
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K930279.
3-WAY HEAD IMMOBILIZER
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K933614 · Bionix Development Corp. · Oct 1993
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K923522 · Radionics Software Applications, Inc. · Aug 1993
MAMMORX
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K925714 · Severn Research, Inc. · Jun 1993