Cleared Traditional

K941169 - TEC 2101 (MODEL MT-HPLGD) (FDA 510(k) Clearance)

Class I Radiology device.

K941169 · Medtec, Inc. · Radiology device
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Jul 1994
Decision
126d
Days
Class 1
Risk

K941169 is an FDA 510(k) clearance for the TEC 2101 (MODEL MT-HPLGD). Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - 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 Medtec, Inc. devices

Submission Details

510(k) Number K941169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date July 18, 1994
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
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.