Cleared Traditional

K854499 - GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR

K854499 is an FDA 510(k) clearance for GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR, manufactured by Gendex Corp.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K854499 · Gendex Corp. · Radiology device
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Apr 1986
Decision
161d
Days
Class 1
Risk

K854499 is an FDA 510(k) clearance for the GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Gendex Corp. (Franklin Park, US). The FDA issued a Cleared decision on April 22, 1986 after a review of 161 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 Gendex Corp. devices

FDA 510(k) Submission Details - K854499

510(k) Number K854499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date April 22, 1986
Days to Decision 161 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 slower than avg
Panel avg: 107d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

IZO Device Classification - Class 1, General Controls

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 100
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K854499.
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
K870851 · Electromed Intl., Ltd. · Mar 1987
SMX GENERATOR
K862800 · General Electric Co. · Aug 1986
MVP GENERATOR, CATALOG NO. H8018
K862682 · General Electric Co. · Jul 1986
FISCHER IMAGING FX325R X-RAY GENERATOR
K860736 · Fischer Imaging Corp. · Apr 1986
EDEC 2000
K852908 · Electromed Intl., Ltd. · Nov 1985
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · Philips Medical Systems (Cleveland), Inc. · Apr 1985