Cleared Traditional

IMPAX OT3000 ORTHOPEDIC WORKSTATION

K040344 · Agfa Corp. · Radiology

May 2004

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K040344 is an FDA 510(k) clearance for the IMPAX OT3000 ORTHOPEDIC WORKSTATION, 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 12, 2004, 90 days after receiving the submission on February 12, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K040344 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2004
Decision Date	May 12, 2004
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF