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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 177
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K103600.
VEX-S 100W INTRAORAL X-RAY SYSTEM
K123493 · VATECH Co., Ltd. · Dec 2012
DENTAL X-RAY Z70 (W)
K122582 · Denterprise International, Inc. · Dec 2012
AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
K111330 · Skanray Technologies · May 2011
INTRA SKAN DC
K103579 · Skanray Technologies · Mar 2011
VISTEO
K093105 · Owandy · Oct 2010
MINXRAY, MODEL: BPD60
K091255 · Minxray, Inc. · May 2010
K103600 · PORTABLE X-RAY SYSTEM
Download PDF FDA Summary Digimed Corporation