Cleared Traditional

K842348 - SPX GENERATOR

K842348 is an FDA 510(k) clearance for SPX GENERATOR, manufactured by General Electric Co.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K842348 · General Electric Co. · Radiology device
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Aug 1984
Decision
63d
Days
Class 1
Risk

K842348 is an FDA 510(k) clearance for the SPX GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by General Electric Co. (Walker, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 63 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 General Electric Co. devices

FDA 510(k) Submission Details - K842348

510(k) Number K842348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date August 17, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
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 99
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K842348.
EDEC 2000
K852908 · Electromed Intl., Ltd. · Nov 1985
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · Philips Medical Systems (Cleveland), Inc. · Apr 1985
EDEC-100
K843443 · Electromed Intl., Ltd. · Mar 1985
PROCESS 100 ST
K833846 · Cgr Medical Corp. · Dec 1983
TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
K820307 · Tecnomed, Inc. · Mar 1982
SIEMENS POLYDOROS 800
K820112 · Siemens Corp. · Feb 1982