Cleared Traditional

K103579 - INTRA SKAN DC

K103579 is an FDA 510(k) clearance for INTRA SKAN DC, manufactured by Skanray Technologies. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K103579 · Skanray Technologies · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
102d
Days
Class 2
Risk

K103579 is an FDA 510(k) clearance for the INTRA SKAN DC. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Skanray Technologies (Mysore, IN). The FDA issued a Cleared decision on March 18, 2011 after a review of 102 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 - K103579

510(k) Number K103579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date March 18, 2011
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K103579.
DENTAL X-RAY Z70 (W)
K122582 · Denterprise International, Inc. · Dec 2012
AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
K111330 · Skanray Technologies · May 2011
PORTABLE X-RAY SYSTEM
K103600 · Digimed Corporation · Apr 2011
VISTEO
K093105 · Owandy · Oct 2010
MINXRAY, MODEL: BPD60
K091255 · Minxray, Inc. · May 2010
BELRAY II
K093240 · Takara Belmont Corp. · Mar 2010
K103579 · INTRA SKAN DC
Download PDF FDA Summary Skanray Technologies