Cleared Traditional

K942100 - MODEL TM EP HIGH VOLTAGE GENERATOR

K942100 is an FDA 510(k) clearance for MODEL TM EP HIGH VOLTAGE GENERATOR, manufactured by Continental X-Ray Corp.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K942100 · Continental X-Ray Corp. · Radiology device
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Jun 1994
Decision
42d
Days
Class 1
Risk

K942100 is an FDA 510(k) clearance for the MODEL TM EP HIGH VOLTAGE GENERATOR. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on June 7, 1994 after a review of 42 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K942100

510(k) Number K942100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1994
Decision Date June 07, 1994
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
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 82
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K942100.
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MOLYBDENUM/RHODIUM FILTERS
K934686 · Continental X-Ray Corp. · May 1994
SCPU X-RAY GENERATOR
K940227 · General Electric Co. · Apr 1994
SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR
K934967 · Shimadzu Corp. · Dec 1993