Cleared Traditional

DRF 4343

K080859 · Villa Sistemi Medicali S.P.A. · Radiology
Jun 2008
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K080859 is an FDA 510(k) clearance for the DRF 4343, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on June 4, 2008, 69 days after receiving the submission on March 27, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K080859 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2008
Decision Date June 04, 2008
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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