Cleared Traditional

K152489 - ENCOMPASS Eagle 3D CBCT/Panoramic/Cepha...

K152489 is the FDA 510(k) clearance for ENCOMPASS Eagle 3D CBCT/Panoramic/Cepha... by Panoramic Corp.. It is a Class 2 Radiology device (product code OAS) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K152489 · Panoramic Corp. · Radiology device
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Feb 2016
Decision
156d
Days
Class 2
Risk

K152489 is an FDA 510(k) clearance for the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by Panoramic Corp. (Ft. Wayne, US). The FDA issued a Cleared decision on February 4, 2016 after a review of 156 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 Panoramic Corp. devices

Submission Details

510(k) Number K152489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2015
Decision Date February 04, 2016
Days to Decision 156 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
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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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