Cleared Traditional

K852019 - BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD

K852019 is an FDA 510(k) clearance for BELMONT AUTOPAN-PAN ORAMIC, manufactured by Belmont Equipment Corp.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K852019 · Belmont Equipment Corp. · Radiology device
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Jun 1985
Decision
28d
Days
Class 2
Risk

K852019 is an FDA 510(k) clearance for the BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Belmont Equipment Corp. (Somerset, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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 Belmont Equipment Corp. devices

FDA 510(k) Submission Details - K852019

510(k) Number K852019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1985
Decision Date June 05, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 - EAP Unit, X-ray, Intraoral

All 9
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K852019.
ATLANTIS
K953936 · Trophy Radiologie · Dec 1995
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
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TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995
PORTARAY
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