Cleared Traditional

WEB1000

K053458 · Agfa Corp. · Radiology
Dec 2005
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K053458 is an FDA 510(k) clearance for the WEB1000, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Agfa Corp. (Waterloo, Ontario, CA). The FDA issued a Cleared decision on December 22, 2005, 9 days after receiving the submission on December 13, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K053458 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2005
Decision Date December 22, 2005
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050