Cleared Special

K072357 - NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM

K072357 is the FDA 510(k) clearance for NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM by Afp Imaging Corp.. It is a Class 2 Radiology device (product code MUH) cleared through the Special 510(k) pathway after a 27-day FDA review.

K072357 · Afp Imaging Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
27d
Days
Class 2
Risk

K072357 is an FDA 510(k) clearance for the NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Afp Imaging Corp. (North Attleboro, US). The FDA issued a Cleared decision on September 18, 2007 after a review of 27 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. 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.

View all Afp Imaging Corp. devices

Submission Details

510(k) Number K072357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2007
Decision Date September 18, 2007
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MUH System, X-ray, Extraoral Source, Digital
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 - MUH System, X-ray, Extraoral Source, Digital

All 74
Devices cleared under the same product code (MUH) and FDA review panel - the closest regulatory comparables to K072357.
XIOS PLUS WALL-MODULE
K081903 · Sirona Dental Systems GmbH · Aug 2008
DENTAL DIGITAL X-RAY IMAGING SYSTEM
K073365 · VATECH Co., Ltd. · Apr 2008
VERAVIEWEPOCS
K073696 · J. Morita USA, Inc. · Apr 2008
GALILEOS
K060892 · Sirona Dental Systems GmbH · Apr 2006
KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
K060079 · Eastman Kodak Company · Feb 2006
VERAVIEW IC 5, MODEL XDP1
K053220 · J. Morita USA, Inc. · Jan 2006