Cleared Traditional

K832989 - BREAST THERMAL ACTIVITY INDICATOR (FDA 510(k) Clearance)

Class I Radiology device.

K832989 · Bcsi Laboratories, Inc. · Radiology device
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Jan 1984
Decision
138d
Days
Class 1
Risk

K832989 is an FDA 510(k) clearance for the BREAST THERMAL ACTIVITY INDICATOR. Classified as System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use) (product code KYA), Class I - General Controls.

Submitted by Bcsi Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2982 - 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. Standard predicate reliance. 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 Bcsi Laboratories, Inc. devices

Submission Details

510(k) Number K832989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1983
Decision Date January 17, 1984
Days to Decision 138 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 107d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYA System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2982
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.