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Breast & Body Health System 2000

FDA 510(k)

Class III (US FDA 510(k))

510(k) K832731

by American Thermal Instruments, Inc.

Identifiers

510(k) Number
K832731 FDA 510(k)
FDA Product Code
KXZ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 884.2982 FDA 510(k)
Regulation Number
884.2982 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Breast & Body Health System 2000 is a thermographic system classified as a nonelectrically powered or AC-powered liquid crystal device. It functions as an adjunct to physical palpation or mammography, displaying heat-sensitive cholesteric liquid crystal patterns on the skin to aid in diagnostic screening for breast cancer or other conditions.

This system is intended for use in clinical settings and is supplied as a reusable device. It operates without electrical power or via AC power and is regulated under FDA 510(k) clearance (K832731) under product code KXZ, falling under device class 3 and regulation number 884.2982. No sterility or single-use specifications are noted in the available data.

Frequently asked questions

What is the Breast & Body Health System 2000 primarily used for in clinical settings?

The Breast & Body Health System 2000 is designed as an adjunct tool to assist in diagnostic screening for breast cancer or other conditions. It displays heat-sensitive cholesteric liquid crystal patterns on the skin, which can help clinicians identify abnormalities during physical palpation or mammography by highlighting thermal variations.

How is the Breast & Body Health System 2000 powered, and what type of environment is it intended for?

The system operates either without electrical power or via AC power, making it versatile for clinical settings where power availability may vary. It is explicitly intended for use in professional healthcare environments, such as hospitals or diagnostic clinics.

Is the Breast & Body Health System 2000 a single-use or reusable device, and what does that mean for maintenance?

The device is classified as reusable, meaning it is designed for repeated use in clinical settings. Since it is not sterile, proper cleaning and maintenance protocols must be followed between uses to ensure accuracy and hygiene, though specific sterilization procedures are not required or mentioned in the available data.

What regulatory pathway was followed for FDA clearance of the Breast & Body Health System 2000?

The device received FDA clearance through a traditional 510(k) pathway, specifically under clearance number K832731. It was reviewed by the Obstetrics/Gynecology advisory committee and classified as substantially equivalent (SESE) to a predicate device, falling under product code KXZ and regulation number 884.2982.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BREAST & BODY HEALTH SYSTEM 2000 (K832731) — FDA 510 (k) | Innolitics, Breast & Body Health System 2000 510 (k) FDA Premarket Notification ..., fda.innolitics.com, FDA 510 (k), K832731, BREAST & BODY HEALTH SYSTEM 2000

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
American Thermal Instruments, Inc.

Sources (1)

  • FDA 510(k) K832731 24 fields · synced Sep 18, 2026