Cleared Traditional

K852908 - EDEC 2000

K852908 is an FDA 510(k) clearance for EDEC 2000, 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 143-day FDA review.

K852908 · Electromed Intl., Ltd. · Radiology device
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Nov 1985
Decision
143d
Days
Class 1
Risk

K852908 is an FDA 510(k) clearance for the EDEC 2000. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Electromed Intl., Ltd. (Quebec, CA). The FDA issued a Cleared decision on November 29, 1985 after a review of 143 days - within the typical 510(k) review window.

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 - K852908

510(k) Number K852908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date November 29, 1985
Days to Decision 143 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
36d slower than avg
Panel avg: 107d · This submission: 143d
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 K852908.
SMX GENERATOR
K862800 · General Electric Co. · Aug 1986
MVP GENERATOR, CATALOG NO. H8018
K862682 · General Electric Co. · Jul 1986
FISCHER IMAGING FX325R X-RAY GENERATOR
K860736 · Fischer Imaging Corp. · Apr 1986
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · Philips Medical Systems (Cleveland), Inc. · Apr 1985
EDEC-100
K843443 · Electromed Intl., Ltd. · Mar 1985
SPX GENERATOR
K842348 · General Electric Co. · Aug 1984