Cleared Traditional

K000412 - VISION R/F TILTING TABLE (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K000412 is an FDA 510(k) clearance for the VISION R/F TILTING TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Villa Sistemi Medicali S.P.A. (Franklin Park, US). The FDA issued a Cleared decision on April 24, 2000 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K000412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 128d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.