Cleared Traditional

K823041 - JEOL MODEL #JTG-500M (FDA 510(k) Clearance)

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

K823041 · Jeol · Radiology device
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Nov 1982
Decision
41d
Days
Class 3
Risk

K823041 is an FDA 510(k) clearance for the JEOL MODEL #JTG-500M. Classified as System, Telethermographic, Infrared (product code IYM), Class III - Premarket Approval.

Submitted by Jeol (Mchenry, US). The FDA issued a Cleared decision on November 24, 1982 after a review of 41 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.

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Submission Details

510(k) Number K823041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1982
Decision Date November 24, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
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.