Cleared Traditional

K895358 - THERMO-5000

K895358 is an FDA 510(k) clearance for THERMO-5000, manufactured by Medtronix Ltd., Inc.. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K895358 · Medtronix Ltd., Inc. · Radiology device
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May 1990
Decision
252d
Days
Class 1
Risk

K895358 is an FDA 510(k) clearance for the THERMO-5000. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Medtronix Ltd., Inc. (Commerce, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 252 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - 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 Medtronix Ltd., Inc. devices

FDA 510(k) Submission Details - K895358

510(k) Number K895358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1989
Decision Date May 07, 1990
Days to Decision 252 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 107d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

LHQ Device Classification - Class 1, General Controls

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
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.