Cleared Traditional

K063047 - MEDHOT MTI 2000 THERMAL IMAGING SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K063047 · Medhot Thermal Imaging, Inc. · Radiology device
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Oct 2006
Decision
15d
Days
Class 1
Risk

K063047 is an FDA 510(k) clearance for the MEDHOT MTI 2000 THERMAL IMAGING SYSTEM. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Medhot Thermal Imaging, Inc. (Great Neck, US). The FDA issued a Cleared decision on October 19, 2006 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medhot Thermal Imaging, Inc. devices

Submission Details

510(k) Number K063047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2006
Decision Date October 19, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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.