Cleared Traditional

K832989 - BREAST THERMAL ACTIVITY INDICATOR

K832989 is an FDA 510(k) clearance for BREAST THERMAL ACTIVITY INDICATOR, manufactured by Bcsi Laboratories, Inc.. The device is a Class 1 Radiology device with product code KYA cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K832989 · Bcsi Laboratories, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K832989

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.

KYA Device Classification - Class 1, General Controls

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.