Cleared Traditional

K791014 - DENTAL XERORADIOGRAPHY

K791014 is an FDA 510(k) clearance for DENTAL XERORADIOGRAPHY, manufactured by Xerox Medical Systems. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K791014 · Xerox Medical Systems · Radiology device
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Sep 1979
Decision
95d
Days
Class 2
Risk

K791014 is an FDA 510(k) clearance for the DENTAL XERORADIOGRAPHY. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Xerox Medical Systems (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 after a review of 95 days - within the typical 510(k) review window.

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: 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 Xerox Medical Systems devices

FDA 510(k) Submission Details - K791014

510(k) Number K791014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1979
Decision Date September 04, 1979
Days to Decision 95 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 107d · This submission: 95d
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 15
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K791014.
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995
PORTARAY
K792535 · Siemens Corp. · Jan 1980
RAFLEX 70
K792437 · Mdt Corp., Inc. · Jan 1980
GE-700 INTRA ORAL X-RAY SYSTEM
K781630 · General Electric Co. · Dec 1978
X-RAY SYSTEM FOR DENTAL APPLICATION
K772184 · General Electric Co. · Dec 1977