Cleared Traditional

K874238 - MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY

K874238 is an FDA 510(k) clearance for MODEL 2001 CP, manufactured by Belmont Equipment Corp.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K874238 · Belmont Equipment Corp. · Radiology device
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Dec 1987
Decision
53d
Days
Class 2
Risk

K874238 is an FDA 510(k) clearance for the MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Belmont Equipment Corp. (Somerset, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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.

FDA 510(k) Submission Details - K874238

510(k) Number K874238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date December 07, 1987
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. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
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 - EHD Unit, X-ray, Extraoral With Timer

All 187
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K874238.
LASER - 1000
K882436 · Panoramic Corp. · Aug 1988
PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE
K875212 · Kevex Corp. · Jun 1988
AXIAL TOME, 60, FLUORO AND TOMAX
K872825 · Axialtome Corp. · Mar 1988
PORTABLE DENTAL X-RAY UNIT MODEL 4000
K872240 · Home/Office Dental, Inc. · Jul 1987
FIAD EXPLOR-X
K871051 · United States Dental · May 1987
PANORAMIC X-RAY MODEL PC-1000
K870236 · Panoramic Corp. · Feb 1987
K874238 · MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY
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