Cleared Traditional

IMPAX CLIENT EMBRACE

K040555 · Agfa Corp. · Radiology
May 2004
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K040555 is an FDA 510(k) clearance for the IMPAX CLIENT EMBRACE, 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 May 26, 2004, 85 days after receiving the submission on March 2, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K040555 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2004
Decision Date May 26, 2004
Days to Decision 85 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