Cleared Traditional

K111167 - XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

K111167 is an FDA 510(k) clearance for XTENDER 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 114-day FDA review.

K111167 · Velopex International, Inc. · Radiology device
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Aug 2011
Decision
114d
Days
Class 2
Risk

K111167 is an FDA 510(k) clearance for the XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT. 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 August 18, 2011 after a review of 114 days - within the typical 510(k) review window.

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: 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 Velopex International, Inc. devices

FDA 510(k) Submission Details - K111167

510(k) Number K111167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2011
Decision Date August 18, 2011
Days to Decision 114 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
7d slower than avg
Panel avg: 107d · This submission: 114d
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 43
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K111167.
FREEDOM AUTOMATIC FILM PROCESSOR
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KODAK MINILOADER(2000)
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K951373 · Fujifilm Medical System U.S.A., Inc. · Oct 1995
KODAK AUTOMIXER II PLUS
K954484 · Eastman Kodak Company · Oct 1995
KODAK X-OMAT 3000 RA PROCESSOR
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KODAK X-OMAT 5000 RA PROCESSOR
K951397 · Eastman Kodak Company · May 1995