Cleared Traditional

K801553 - THERMOCOMP (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K801553 · Hospital Financial Corp. · Radiology device
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Oct 1980
Decision
115d
Days
Class 3
Risk

K801553 is an FDA 510(k) clearance for the THERMOCOMP. Classified as System, Telethermographic, Infrared (product code IYM), Class III - Premarket Approval.

Submitted by Hospital Financial Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 115 days - within the typical 510(k) review window.

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: High-complexity regulatory submission. High regulatory complexity profile. 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 Hospital Financial Corp. devices

Submission Details

510(k) Number K801553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date October 31, 1980
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYM System, Telethermographic, Infrared
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.2980
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.