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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 77
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K111167.
INTRAX FILM PROCESSOR
K093503 · Velopex International, Inc. · Jan 2010
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX
K091628 · Protec GmbH & Co. KG · Aug 2009
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K024342 · Daito Co., Ltd. · Apr 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
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
K111167 · XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
Download PDF FDA Summary Velopex International…