Cleared Traditional

K093503 - INTRAX FILM PROCESSOR

K093503 is an FDA 510(k) clearance for INTRAX FILM PROCESSOR, manufactured by Velopex International, Inc.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K093503 · Velopex International, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
55d
Days
Class 2
Risk

K093503 is an FDA 510(k) clearance for the INTRAX FILM PROCESSOR. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Velopex International, Inc. (St. Cloud, US). The FDA issued a Cleared decision on January 6, 2010 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K093503

510(k) Number K093503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2009
Decision Date January 06, 2010
Days to Decision 55 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
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - IXW Processor, Radiographic-film, Automatic

All 77
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K093503.
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
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K023801 · S.A.I.E.P. S.R.L. · Feb 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
K023825 · S.A.I.E.P. S.R.L. · Feb 2003
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
K023613 · Alphatek Corp. · Jan 2003
K093503 · INTRAX FILM PROCESSOR
Download PDF FDA Summary Velopex International…