Cleared Traditional

K990416 - OMNICORDER BIOSCAN SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K990416 · Omnicorder Technologies, Inc. · Radiology device
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Dec 1999
Decision
316d
Days
Class 1
Risk

K990416 is an FDA 510(k) clearance for the OMNICORDER BIOSCAN SYSTEM. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Omnicorder Technologies, Inc. (Stony Brook, US). The FDA issued a Cleared decision on December 23, 1999 after a review of 316 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: Standard predicate-based submission. Elevated predicate reliance 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 Omnicorder Technologies, Inc. devices

Submission Details

510(k) Number K990416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1999
Decision Date December 23, 1999
Days to Decision 316 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
209d slower than avg
Panel avg: 107d · This submission: 316d
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.