Cleared Special

K133271 - OPTEO, VIDEOGRAPH HD

K133271 is an FDA 510(k) clearance for OPTEO, manufactured by Owandy. The device is a Class 2 Radiology device with product code MUH cleared through the Special 510(k) pathway after a 186-day FDA review.

K133271 · Owandy · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
186d
Days
Class 2
Risk

K133271 is an FDA 510(k) clearance for the OPTEO, VIDEOGRAPH HD. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Owandy (Ormond Beach, US). The FDA issued a Cleared decision on April 28, 2014 after a review of 186 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133271

510(k) Number K133271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2013
Decision Date April 28, 2014
Days to Decision 186 days
Submission Type Special
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
79d slower than avg
Panel avg: 107d · This submission: 186d
Pathway characteristics
Modification to existing cleared device.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
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 - MUH System, X-ray, Extraoral Source, Digital

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