Cleared Traditional

K875342 - EDEC 90C

K875342 is the FDA 510(k) clearance for EDEC 90C by Electromed Intl., Ltd.. It is a Class 1 Radiology device (product code IZO) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K875342 · Electromed Intl., Ltd. · Radiology device
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Jan 1988
Decision
30d
Days
Class 1
Risk

K875342 is an FDA 510(k) clearance for the EDEC 90C. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Electromed Intl., Ltd. (Canada, CA). The FDA issued a Cleared decision on January 29, 1988 after a review of 30 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 Electromed Intl., Ltd. devices

Submission Details

510(k) Number K875342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1987
Decision Date January 29, 1988
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
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 78
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K875342.
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SMX GENERATOR
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MVP GENERATOR, CATALOG NO. H8018
K862682 · General Electric Co. · Jul 1986
FISCHER IMAGING FX325R X-RAY GENERATOR
K860736 · Fischer Imaging Corp. · Apr 1986