Cleared Traditional

K871145 - EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR

K871145 is an FDA 510(k) clearance for EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR, 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 8-day FDA review.

K871145 · Electromed Intl., Ltd. · Radiology device
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Mar 1987
Decision
8d
Days
Class 1
Risk

K871145 is an FDA 510(k) clearance for the EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR. 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 March 31, 1987 after a review of 8 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

FDA 510(k) Submission Details - K871145

510(k) Number K871145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1987
Decision Date March 31, 1987
Days to Decision 8 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
99d faster than avg
Panel avg: 107d · This submission: 8d
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 K871145.
EDEC 60R
K880050 · Electromed Intl., Ltd. · Feb 1988
EDEC 60 R/F
K875341 · Electromed Intl., Ltd. · Feb 1988
EDEC 90C
K875342 · Electromed Intl., Ltd. · Jan 1988
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