Cleared Traditional

K840275 - CEHPALOMETRIC HEAD POSITIONER (FDA 510(k) Clearance)

Class I Radiology device.

K840275 · Gary E. Hall, Dds · Radiology device
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Mar 1984
Decision
53d
Days
Class 1
Risk

K840275 is an FDA 510(k) clearance for the CEHPALOMETRIC HEAD POSITIONER. Classified as Cone, Radiographic, Lead-lined (product code EAH), Class I - General Controls.

Submitted by Gary E. Hall, Dds. The FDA issued a Cleared decision on March 16, 1984 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1850 - 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 Gary E. Hall, Dds devices

Submission Details

510(k) Number K840275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date March 16, 1984
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAH Cone, Radiographic, Lead-lined
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.1850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.