Cleared Traditional

K864339 - PORTA RAY MODEL 325

K864339 is an FDA 510(k) clearance for PORTA RAY MODEL 325, manufactured by Porta Ray, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K864339 · Porta Ray, Inc. · Radiology device
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Dec 1986
Decision
41d
Days
Class 1
Risk

K864339 is an FDA 510(k) clearance for the PORTA RAY MODEL 325. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Porta Ray, Inc. (Deer Park, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Porta Ray, Inc. devices

FDA 510(k) Submission Details - K864339

510(k) Number K864339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date December 15, 1986
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
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 K864339.
EDEC 90C
K875342 · Electromed Intl., Ltd. · Jan 1988
EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR
K871145 · Electromed Intl., Ltd. · Mar 1987
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