Cleared Traditional

K103600 - PORTABLE X-RAY SYSTEM

K103600 is an FDA 510(k) clearance for PORTABLE X-RAY SYSTEM, manufactured by Digimed Corporation. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K103600 · Digimed Corporation · Radiology device
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Apr 2011
Decision
121d
Days
Class 2
Risk

K103600 is an FDA 510(k) clearance for the PORTABLE X-RAY SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Digimed Corporation (Buffalo Grove, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 121 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 Digimed Corporation devices

FDA 510(k) Submission Details - K103600

510(k) Number K103600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2010
Decision Date April 08, 2011
Days to Decision 121 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
14d slower than avg
Panel avg: 107d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 103
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K103600.
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K091255 · Minxray, Inc. · May 2010
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
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PLANMECA PROSENSOR
K091197 · Planmeca Oy · Jul 2009