Cleared Traditional

K863818 - PM-100 THERMOGRAPH MARK 1026 (FDA 510(k) Clearance)

Class I Radiology device.

K863818 · Clearwater Computer Center, Inc. · Radiology device
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Apr 1987
Decision
185d
Days
Class 1
Risk

K863818 is an FDA 510(k) clearance for the PM-100 THERMOGRAPH MARK 1026. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Clearwater Computer Center, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 185 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 Clearwater Computer Center, Inc. devices

Submission Details

510(k) Number K863818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date April 03, 1987
Days to Decision 185 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 107d · This submission: 185d
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.