Cleared Special

K013176 - MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE

K013176 is an FDA 510(k) clearance for MODIFICATION TO: SENS-A-RAY SYSTEM WITH..., 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 22-day FDA review.

K013176 · Afp Imaging Corp. · Radiology device
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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

FDA 510(k) Submission Details - K013176

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.

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 K013176.
A/T X-RAY 70
K024285 · Air Techniques, Inc. · Apr 2003
MODIFICATION TO FOCUS
K022630 · Instrumentarium Corp. · Oct 2002
VERAVIEWEPOCS, MODEL VE
K013955 · J. Morita USA, Inc. · Feb 2002
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · Planmeca Oy · Jun 2001
FOCUS
K001729 · Instrumentarium Corp. · Jul 2000
DIMAX 2
K000771 · Planmeca Oy · May 2000