Cleared Abbreviated

APOLLO

K050190 · Villa Sistemi Medicali S.P.A. · Radiology
Mar 2005
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K050190 is an FDA 510(k) clearance for the APOLLO, a Table, Radiologic (Class II — Special Controls, product code KXJ), submitted by Villa Sistemi Medicali S.P.A. (Franklin Park, US). The FDA issued a Cleared decision on March 25, 2005, 57 days after receiving the submission on January 27, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K050190 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2005
Decision Date March 25, 2005
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KXJ — Table, Radiologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980