Cleared Traditional

K133620 - CONE BEAM 3D AND 2D PANORAMIC DENTAL IM...

K133620 is an FDA 510(k) clearance for CONE BEAM 3D AND 2D PANORAMIC DENTAL IM..., manufactured by Imaging Sciences International. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K133620 · Imaging Sciences International · Radiology device
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May 2014
Decision
170d
Days
Class 2
Risk

K133620 is an FDA 510(k) clearance for the CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Imaging Sciences International (Hatfield, US). The FDA issued a Cleared decision on May 14, 2014 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Imaging Sciences International devices

FDA 510(k) Submission Details - K133620

510(k) Number K133620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date May 14, 2014
Days to Decision 170 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
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
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 - OAS X-ray, Tomography, Computed, Dental

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