Cleared Traditional

K962631 - DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM

K962631 is an FDA 510(k) clearance for DEXIS MODEL 601 DENTAL ELECTRONIC IMAGI..., manufactured by Fair Image, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K962631 · Fair Image, Inc. · Radiology device
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Nov 1996
Decision
144d
Days
Class 2
Risk

K962631 is an FDA 510(k) clearance for the DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Fair Image, Inc. (Concord, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 144 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fair Image, Inc. devices

FDA 510(k) Submission Details - K962631

510(k) Number K962631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1996
Decision Date November 26, 1996
Days to Decision 144 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
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 117
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K962631.
ACURAY DIGITAL X-RAY
K963403 · New Image Industries, Inc. · Jan 1997
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
K963699 · Belmont Equipment Corp. · Dec 1996
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
K964659 · Dentsply Intl. · Dec 1996
ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER
K963185 · Electronic Control Concepts · Oct 1996
DIGIPAN
K961826 · Trophy Radiologie · Sep 1996
TOMOGRAPH ACCESSORIES
K962120 · Steri-Oss, Inc. · Jul 1996