Cleared Special

K030647 - EVA DIGITAL DENTAL X-RAY SYSTEM

K030647 is an FDA 510(k) clearance for EVA DIGITAL DENTAL X-RAY SYSTEM, manufactured by Afp Imaging Corp.. The device is a Class 2 Radiology device with product code EHD cleared through the Special 510(k) pathway after a 20-day FDA review.

K030647 · Afp Imaging Corp. · Radiology device
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Mar 2003
Decision
20d
Days
Class 2
Risk

K030647 is an FDA 510(k) clearance for the EVA DIGITAL DENTAL X-RAY SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Afp Imaging Corp. (North Attleboro, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 20 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

FDA 510(k) Submission Details - K030647

510(k) Number K030647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2003
Decision Date March 20, 2003
Days to Decision 20 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
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 138
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K030647.
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K011619 · Planmeca Oy · Jun 2001