Cleared Abbreviated

K030185 - ENDOS AC/ACP

K030185 is an FDA 510(k) clearance for ENDOS AC/ACP, manufactured by Villa Sistemi Medicali S.P.A.. The device is a Class 2 Radiology device with product code EHD cleared through the Abbreviated 510(k) pathway after a 49-day FDA review.

K030185 · Villa Sistemi Medicali S.P.A. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
49d
Days
Class 2
Risk

K030185 is an FDA 510(k) clearance for the ENDOS AC/ACP. 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 March 11, 2003 after a review of 49 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 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.

FDA 510(k) Submission Details - K030185

510(k) Number K030185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date March 11, 2003
Days to Decision 49 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Standards-based clearance path.

EHD Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K030185.
INTRAOS 70
K031118 · Blue X Imaging Srl · Jul 2003
A/T X-RAY 70
K024285 · Air Techniques, Inc. · Apr 2003
EVA DIGITAL DENTAL X-RAY SYSTEM
K030647 · Afp Imaging Corp. · Mar 2003
MODIFICATION TO FOCUS
K022630 · Instrumentarium Corp. · Oct 2002
PORTABLE HDX INTRAORAL X-RAY
K021378 · Dentalez Group · Jun 2002
DEGOTZEN SYNCHRO
K021245 · The Gotzen Group, Inc. · May 2002
K030185 · ENDOS AC/ACP
Download PDF FDA Summary Villa Sistemi Medical…