Cleared Traditional

K832731 - BREAST & BODY HEALTH SYSTEM 2000

K832731 is an FDA 510(k) clearance for BREAST & BODY HEALTH SYSTEM 2000, manufactured by American Thermal Instruments, Inc.. The device is a Class 3 Radiology device with product code KXZ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

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.

FDA 510(k) Submission Details - K832731

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 107d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

KXZ Device Classification - Class 3, Premarket Approval

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.

Regulatory Peers - KXZ System, Thermographic, Liquid Crystal, Powered (adjunctive Use)

Devices cleared under the same product code (KXZ) and FDA review panel - the closest regulatory comparables to K832731.
NOVATHERM
K851034 · Medtech Products, Inc. · Sep 1985
Q-SCAN THERMOGRAPHY SYSTEM
K843124 · Qmax Medical, Inc. · Nov 1984
THERMASCAN
K813547 · Bcd Products, Inc. · Mar 1982
FLEXT-THERM
K781916 · E-Z-Em, Inc. · Feb 1979
FLEXI-THERM FILM
K770986 · E-Z-Em, Inc. · Sep 1977
ELC-THERMO-SYSTEM
K770678 · Cutter Laboratories, Inc. · May 1977
K832731 · BREAST & BODY HEALTH SYSTEM 2000
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