Cleared Special

ADC QS/IPD WORKSTATION

K010571 · Agfa Corp. · Radiology
Mar 2001
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K010571 is an FDA 510(k) clearance for the ADC QS/IPD WORKSTATION, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Agfa Corp. (Rockville, US). The FDA issued a Cleared decision on March 28, 2001, 30 days after receiving the submission on February 26, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K010571 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2001
Decision Date March 28, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050