Cleared Traditional

K111330 - AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY

K111330 is an FDA 510(k) clearance for AIR TECHNIQUES HIGH FREQUENCY INTRA-ORA..., 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 16-day FDA review.

K111330 · Skanray Technologies · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
16d
Days
Class 2
Risk

K111330 is an FDA 510(k) clearance for the AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY. 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 May 27, 2011 after a review of 16 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K111330

510(k) Number K111330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2011
Decision Date May 27, 2011
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
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 S 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 K111330.
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K093105 · Owandy · Oct 2010
K111330 · AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
Download PDF FDA Summary Skanray Technologies