Cleared Special

K110260 - NEWTOM 5G / NEWTOM 5G VERSION FP

K110260 is an FDA 510(k) clearance for NEWTOM 5G / NEWTOM 5G VERSION FP, manufactured by Qr S.R.L.. The device is a Class 2 Radiology device with product code OAS cleared through the Special 510(k) pathway after a 68-day FDA review.

K110260 · Qr S.R.L. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
68d
Days
Class 2
Risk

K110260 is an FDA 510(k) clearance for the NEWTOM 5G / NEWTOM 5G VERSION FP. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Qr S.R.L. (Verona, IT). The FDA issued a Cleared decision on April 6, 2011 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110260

510(k) Number K110260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2011
Decision Date April 06, 2011
Days to Decision 68 days
Submission Type Special
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
39d faster than avg
Panel avg: 107d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 - OAS X-ray, Tomography, Computed, Dental

All 134
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K110260.
CS 9300, CS 9300C
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SCANORA 3D
K110839 · Soredex Palodex Group OY · Jun 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · VATECH Co., Ltd. · Mar 2011
ORTHOPHOS XG 3D / CEPH
K103711 · Sirona Dental Systems GmbH · Mar 2011
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K090467 · VATECH Co., Ltd. · Jan 2010