Cleared Traditional

K050239 - EMD THERMOGRAPHY SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K050239 · Em Diagnostics, Inc. · Radiology device
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Mar 2006
Decision
407d
Days
Class 1
Risk

K050239 is an FDA 510(k) clearance for the EMD THERMOGRAPHY SYSTEM. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Em Diagnostics, Inc. (Stamford, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 407 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Em Diagnostics, Inc. devices

Submission Details

510(k) Number K050239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2005
Decision Date March 16, 2006
Days to Decision 407 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
300d slower than avg
Panel avg: 107d · This submission: 407d
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.