Cleared Traditional

EDEC-100 (K843443) - FDA 510(k) Clearance

Class I Radiology device.

K843443 · Electromed Intl., Ltd. · Radiology device
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Mar 1985
Decision
178d
Days
Class 1
Risk

K843443 is an FDA 510(k) clearance for the EDEC-100. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Electromed Intl., Ltd. (Willoughby, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 178 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 Electromed Intl., Ltd. devices

Submission Details

510(k) Number K843443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date March 01, 1985
Days to Decision 178 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 107d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 26
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K843443.
SMX GENERATOR
K862800 · General Electric Co. · Aug 1986
MVP GENERATOR, CATALOG NO. H8018
K862682 · General Electric Co. · Jul 1986
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · Philips Medical Systems (Cleveland), Inc. · Apr 1985
SPX GENERATOR
K842348 · General Electric Co. · Aug 1984
ECCO GENERATOR
K811198 · Philips Medical Systems (Cleveland), Inc. · Jun 1981
VECTOR-100 X-RAY GENERATOR
K802996 · Philips Medical Systems (Cleveland), Inc. · Jan 1981