Cleared Special

K013176 - MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013176 · Afp Imaging Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
22d
Days
Class 2
Risk

K013176 is an FDA 510(k) clearance for the MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE. 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 October 16, 2001 after a review of 22 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 K013176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2001
Decision Date October 16, 2001
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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