Cleared Traditional

K843443 - EDEC-100

K843443 is an FDA 510(k) clearance for EDEC-100, manufactured by Electromed Intl., Ltd.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 178-day FDA review.

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

FDA 510(k) Submission Details - K843443

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 107d · This submission: 178d
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 K843443.
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SPX GENERATOR
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PROCESS 100 ST
K833846 · Cgr Medical Corp. · Dec 1983
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K820307 · Tecnomed, Inc. · Mar 1982