Cleared Traditional

K950442 - INFRARED EXPOSURE HAND SWITCH (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950442 · Medical X-Ray Intl., Inc. · Radiology device
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Mar 1995
Decision
63d
Days
Class 2
Risk

K950442 is an FDA 510(k) clearance for the INFRARED EXPOSURE HAND SWITCH. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Medical X-Ray Intl., Inc. (Keyport, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Medical X-Ray Intl., Inc. devices

Submission Details

510(k) Number K950442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date March 31, 1995
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXJ Table, Radiologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.