Cleared Traditional

K812701 - ORTHO-THERM INFRARED SENSOR (FDA 510(k) Clearance)

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

K812701 · Orthion Corp. · Radiology device
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Oct 1981
Decision
20d
Days
Class 3
Risk

K812701 is an FDA 510(k) clearance for the ORTHO-THERM INFRARED SENSOR. Classified as System, Telethermographic, Infrared (product code IYM), Class III - Premarket Approval.

Submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 20 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. 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 Orthion Corp. devices

Submission Details

510(k) Number K812701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1981
Decision Date October 13, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
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.