Cleared Traditional

K110371 - ENCOMPASS HF100- EAGLE PANORAMIC/CEPHAL...

K110371 is the FDA 510(k) clearance for ENCOMPASS HF100- EAGLE PANORAMIC/CEPHAL... by Panoramic Corp.. It is a Class 2 Radiology device (product code MUH) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K110371 · Panoramic Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2011
Decision
37d
Days
Class 2
Risk

K110371 is an FDA 510(k) clearance for the ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Panoramic Corp. (Naples, US). The FDA issued a Cleared decision on March 17, 2011 after a review of 37 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.

View all Panoramic Corp. devices

Submission Details

510(k) Number K110371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2011
Decision Date March 17, 2011
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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

All 74
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