Cleared Traditional

K872962 - BREAST-SCAN(TM) (FDA 510(k) Clearance)

Class I Radiology device.

K872962 · Thermascan, Inc. · Radiology device
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Oct 1987
Decision
83d
Days
Class 1
Risk

K872962 is an FDA 510(k) clearance for the BREAST-SCAN(TM). Classified as System, Thermographic, Liquid Crystal (product code LHM), Class I - General Controls.

Submitted by Thermascan, Inc. (New York, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 83 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thermascan, Inc. devices

Submission Details

510(k) Number K872962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1987
Decision Date October 20, 1987
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHM System, Thermographic, Liquid Crystal
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.