Cleared Traditional

XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

K111167 · Velopex International, Inc. · Radiology

Aug 2011

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K111167 is an FDA 510(k) clearance for the XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT, a Processor, Radiographic-film, Automatic (Class II — Special Controls, product code IXW), submitted by Velopex International, Inc. (St. Cloud, US). The FDA issued a Cleared decision on August 18, 2011, 114 days after receiving the submission on April 26, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number	K111167 FDA.gov
FDA Decision	Cleared 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