Cleared Traditional

K171928 - Med-Hot Thermal Imaging Systems

K171928 is an FDA 510(k) clearance for Med-Hot Thermal Imaging Systems, manufactured by Med-Hot Thermal Imaging, Inc.. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K171928 · Med-Hot Thermal Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K171928

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
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.

Regulatory Consultant

Smith Associates
E. J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LHQ System, Telethermographic (adjunctive Use)

All 33
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K171928 · Med-Hot Thermal Imaging Systems
Download PDF FDA Summary Med-Hot Thermal Imagi…