Cleared Traditional

IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO

K022292 · Agfa Corp. · Radiology

Sep 2002

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K022292 is an FDA 510(k) clearance for the IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Agfa Corp. (Brevard, US). The FDA issued a Cleared decision on September 12, 2002, 59 days after receiving the submission on July 15, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K022292 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2002
Decision Date	September 12, 2002
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF