Cleared Special

IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X

K050751 · Agfa Corp. · Radiology

Apr 2005

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K050751 is an FDA 510(k) clearance for the IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on April 21, 2005, 29 days after receiving the submission on March 23, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K050751 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2005
Decision Date	April 21, 2005
Days to Decision	29 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF