Cleared Abbreviated

K130109 - ENDOGRAPH DC (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K130109 · Villa Sistemi Medicali S.P.A. · Radiology device
Aug 2013
Decision
197d
Days
Class 2
Risk

K130109 is an FDA 510(k) clearance for the ENDOGRAPH DC. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, Milano, IT). The FDA issued a Cleared decision on August 1, 2013 after a review of 197 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K130109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2013
Decision Date August 01, 2013
Days to Decision 197 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 128d · This submission: 197d
Pathway characteristics
Standards-based clearance path.

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.

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