Cleared Traditional

K152489 - ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray

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

K152489 · Panoramic Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K152489

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Kamm & Associates
Daniel Kamm

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 - OAS X-ray, Tomography, Computed, Dental

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