Cleared Traditional

Med-Hot Thermal Imaging Systems (K171928) - FDA 510(k) Clearance

Class I Radiology device.

K171928 · Med-Hot Thermal Imaging, Inc. · Radiology device
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Dec 2017
Decision
164d
Days
Class 1
Risk

K171928 is an FDA 510(k) clearance for the Med-Hot Thermal Imaging Systems. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Med-Hot Thermal Imaging, Inc. (Lakeland, US). The FDA issued a Cleared decision on December 8, 2017 after a review of 164 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 Med-Hot Thermal Imaging, Inc. devices

Submission Details

510(k) Number K171928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2017
Decision Date December 08, 2017
Days to Decision 164 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.

Regulatory Peers - LHQ System, Telethermographic (adjunctive Use)

All 40
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