Cleared Traditional

K063047 - MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

K063047 is an FDA 510(k) clearance for MEDHOT MTI 2000 THERMAL IMAGING SYSTEM, manufactured by Medhot Thermal Imaging, Inc.. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K063047 · Medhot Thermal Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K063047

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
Combination Product No
PCCP Authorized No
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.

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

Citech
ROBERT MOSENKIS

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 40
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K063047 · MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
Download PDF FDA Summary Medhot Thermal Imagin…