Cleared Traditional

ADC PEDIATRIC

K012750 · Agfa Corp. · Radiology
Nov 2001
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K012750 is an FDA 510(k) clearance for the ADC PEDIATRIC, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Agfa Corp. (Rockville, US). The FDA issued a Cleared decision on November 14, 2001, 90 days after receiving the submission on August 16, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K012750 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2001
Decision Date November 14, 2001
Days to Decision 90 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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