Cleared Traditional

K963403 - ACURAY DIGITAL X-RAY

K963403 is an FDA 510(k) clearance for ACURAY DIGITAL X-RAY, manufactured by New Image Industries, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K963403 · New Image Industries, Inc. · Radiology device
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Jan 1997
Decision
126d
Days
Class 2
Risk

K963403 is an FDA 510(k) clearance for the ACURAY DIGITAL X-RAY. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by New Image Industries, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 2, 1997 after a review of 126 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 New Image Industries, Inc. devices

FDA 510(k) Submission Details - K963403

510(k) Number K963403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1996
Decision Date January 02, 1997
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
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 K963403.
RADX SYSTEM
K965203 · Electro Medical Systems, Inc. · Mar 1997
PM 2002 CC PROLINE
K970263 · Planmeca Oy · Feb 1997
PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
K965072 · Kaycor Intl., Ltd. · 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
DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM
K962631 · Fair Image, Inc. · Nov 1996