Cleared Traditional

VISION R/F TILTING TABLE

K000412 · Villa Sistemi Medicali S.P.A. · Radiology
Apr 2000
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K000412 is an FDA 510(k) clearance for the VISION R/F TILTING TABLE, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by Villa Sistemi Medicali S.P.A. (Franklin Park, US). The FDA issued a Cleared decision on April 24, 2000, 76 days after receiving the submission on February 8, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K000412 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2000
Decision Date April 24, 2000
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXR — Table, Radiographic, Tilting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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