Cleared Traditional

K955236 - GREEN TEC-2100

K955236 is an FDA 510(k) clearance for GREEN TEC-2100, manufactured by Medtec, Inc.. The device is a Class 1 Radiology device with product code IWE cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K955236 · Medtec, Inc. · Radiology device
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May 1996
Decision
192d
Days
Class 1
Risk

K955236 is an FDA 510(k) clearance for the GREEN TEC-2100. 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 May 24, 1996 after a review of 192 days - an extended review cycle.

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

FDA 510(k) Submission Details - K955236

510(k) Number K955236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1995
Decision Date May 24, 1996
Days to Decision 192 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
85d slower than avg
Panel avg: 107d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

IWE Device Classification - Class 1, General Controls

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.

Regulatory Peers - IWE Monitor, Patient Position, Light-beam

All 11
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