Cleared Special

K232462 - ThermPix Thermovisual Camera (FDA 510(k) Clearance)

Class I Radiology device.

K232462 · Usa Therm, Inc. · Radiology device
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Sep 2023
Decision
30d
Days
Class 1
Risk

K232462 is an FDA 510(k) clearance for the ThermPix Thermovisual Camera. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Usa Therm, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 14, 2023 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Usa Therm, Inc. devices

Submission Details

510(k) Number K232462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2023
Decision Date September 14, 2023
Days to Decision 30 days
Submission Type Special
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Medical Device Academy
Mary Vater

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.