Cleared Traditional

K832731 - BREAST & BODY HEALTH SYSTEM 2000 (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K832731 · American Thermal Instruments, Inc. · Radiology device
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Jan 1984
Decision
179d
Days
Class 3
Risk

K832731 is an FDA 510(k) clearance for the BREAST & BODY HEALTH SYSTEM 2000. Classified as System, Thermographic, Liquid Crystal, Powered (adjunctive Use) (product code KXZ), Class III - Premarket Approval.

Submitted by American Thermal Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 179 days - an extended review 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: High-complexity regulatory submission. High regulatory complexity 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 American Thermal Instruments, Inc. devices

Submission Details

510(k) Number K832731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date January 30, 1984
Days to Decision 179 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 107d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KXZ System, Thermographic, Liquid Crystal, Powered (adjunctive Use)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.2982
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.