Cleared Traditional

DX-SI

K063421 · Agfa Corp. · Radiology
Nov 2006
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K063421 is an FDA 510(k) clearance for the DX-SI, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on November 22, 2006, 9 days after receiving the submission on November 13, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K063421 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2006
Decision Date November 22, 2006
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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