Cleared Traditional

K002432 - STRATO X

K002432 is the FDA 510(k) clearance for STRATO X by Villa Sistemi Medicali S.P.A.. It is a Class 2 Radiology device (product code EHD) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K002432 · Villa Sistemi Medicali S.P.A. · Radiology device
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Sep 2000
Decision
24d
Days
Class 2
Risk

K002432 is an FDA 510(k) clearance for the STRATO X. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Villa Sistemi Medicali S.P.A. (Franklin Park, US). The FDA issued a Cleared decision on September 1, 2000 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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.

View all Villa Sistemi Medicali S.P.A. devices

Submission Details

510(k) Number K002432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2000
Decision Date September 01, 2000
Days to Decision 24 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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.

Regulatory Peers - EHD Unit, X-ray, Extraoral With Timer

All 66
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