Cleared Traditional

K843549 - PROBEYE THERMAL VIDEO SYSTEMS (FDA 510(k) Clearance)

Class I Radiology device.

K843549 · Hughes Aircraft Co. · Radiology device
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Feb 1985
Decision
154d
Days
Class 1
Risk

K843549 is an FDA 510(k) clearance for the PROBEYE THERMAL VIDEO SYSTEMS. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Hughes Aircraft Co. (Carlsbad, US). The FDA issued a Cleared decision on February 11, 1985 after a review of 154 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.

View all Hughes Aircraft Co. devices

Submission Details

510(k) Number K843549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date February 11, 1985
Days to Decision 154 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 107d · This submission: 154d
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.