Cleared Traditional

K834279 - ACURAY 071A DENTAL INTRAORAL X-RAY

K834279 is an FDA 510(k) clearance for ACURAY 071A DENTAL INTRAORAL X-RAY, 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 37-day FDA review.

K834279 · Belmont Equipment Corp. · Radiology device
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Dec 1983
Decision
37d
Days
Class 2
Risk

K834279 is an FDA 510(k) clearance for the ACURAY 071A DENTAL INTRAORAL X-RAY. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Belmont Equipment Corp. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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 - K834279

510(k) Number K834279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1983
Decision Date December 29, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 K834279.
ATLANTIS
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