Cleared Traditional

K181716 - InTouch Thermal Camera (FDA 510(k) Clearance)

Class I Radiology device.

K181716 · Intouch Technologies, Inc., D.B.A. Intouch Health · Radiology device
Mar 2019
Decision
270d
Days
Class 1
Risk

K181716 is an FDA 510(k) clearance for the InTouch Thermal Camera. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Intouch Technologies, Inc., D.B.A. Intouch Health (Goleta, US). The FDA issued a Cleared decision on March 25, 2019 after a review of 270 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.

Submission Details

510(k) Number K181716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2018
Decision Date March 25, 2019
Days to Decision 270 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 128d · This submission: 270d
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.