Cleared Traditional

K020073 - MEDICAL ADMINISTRATOR (FDA 510(k) Clearance)

Jul 2002
Decision
184d
Days
Class 2
Risk

K020073 is an FDA 510(k) clearance for the MEDICAL ADMINISTRATOR. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Barco N.V. (La Jolla, US). The FDA issued a Cleared decision on July 12, 2002, 184 days after receiving the submission on January 9, 2002.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K020073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2002
Decision Date July 12, 2002
Days to Decision 184 days
Submission Type Traditional
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