Cleared Abbreviated

ENDOGRAPH DC

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

About This 510(k) Submission

K130109 is an FDA 510(k) clearance for the ENDOGRAPH DC, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, Milano, IT). The FDA issued a Cleared decision on August 1, 2013, 197 days after receiving the submission on January 16, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K130109 FDA.gov
FDA Decision Cleared 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

Device Classification

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

Similar Devices — EHD Unit, X-ray, Extraoral With Timer

All 187
Dental X-RAY Unit (AJX200)
K252110 · Guangzhou Ajax Medical Equipment Co., Ltd. · Mar 2026
Portable Dental X-ray Device (GT-1)
K254018 · Guilin Refine Medical Instrument Co., Ltd. · Feb 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · Ningbo Runyes Medical Instrument Co., Ltd. · Feb 2026
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2025
Rextar Pro
K242185 · Raypia Co., Ltd. · Dec 2024
XERO-alpha
K242591 · DRTECH Corporation · Nov 2024