Cleared Special

K123419 - EVA SELECT DIGITAL DENTAL IMAGING SYSTEM

K123419 is an FDA 510(k) clearance for EVA SELECT DIGITAL DENTAL IMAGING SYSTEM, manufactured by Afp Imaging Corp.. The device is a Class 2 Radiology device with product code MUH cleared through the Special 510(k) pathway after a 51-day FDA review.

K123419 · Afp Imaging Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
51d
Days
Class 2
Risk

K123419 is an FDA 510(k) clearance for the EVA SELECT DIGITAL DENTAL IMAGING SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Afp Imaging Corp. (Naples, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 51 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.

FDA 510(k) Submission Details - K123419

510(k) Number K123419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2012
Decision Date December 27, 2012
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

MUH Device Classification - Class 2, Special Controls

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

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K123419 · EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
Download PDF FDA Summary Afp Imaging Corp.