Cleared Abbreviated

K090749 - ROOGRAPH EVO

K090749 is the FDA 510(k) clearance for ROOGRAPH EVO by Villa Sistemi Medicali S.P.A.. It is a Class 2 Radiology device (product code EHD) cleared through the Abbreviated 510(k) pathway after a 59-day FDA review.

K090749 · Villa Sistemi Medicali S.P.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
59d
Days
Class 2
Risk

K090749 is an FDA 510(k) clearance for the ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on May 18, 2009 after a review of 59 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.

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

Submission Details

510(k) Number K090749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date May 18, 2009
Days to Decision 59 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
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.

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

All 66
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K090749.
PORTABLE X-RAY SYSTEM
K122124 · Osstem Implant Co., Ltd. · May 2013
VEX-S 100W INTRAORAL X-RAY SYSTEM
K123493 · VATECH Co., Ltd. · Dec 2012
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
K092103 · VATECH Co., Ltd. · Oct 2009
HELIODENT PLUS
K083344 · Sirona Dental Systems GmbH · Dec 2008
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
K040556 · Eastman Kodak Company · Apr 2004
ORTHOPHOS XG DS/CEPH
K033073 · Sirona Dental Systems GmbH · Oct 2003