Cleared Traditional

K041120 - EV APAN DIGITAL

K041120 is the FDA 510(k) clearance for EV APAN DIGITAL by Afp Imaging Corp.. It is a Class 2 Radiology device (product code MUH) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K041120 · Afp Imaging Corp. · Radiology device
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Aug 2004
Decision
123d
Days
Class 2
Risk

K041120 is an FDA 510(k) clearance for the EV APAN DIGITAL, MODEL K1VSM2000. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Afp Imaging Corp. (Elmsford, US). The FDA issued a Cleared decision on August 30, 2004 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Afp Imaging Corp. devices

Submission Details

510(k) Number K041120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2004
Decision Date August 30, 2004
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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