Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2982](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2982) → KYA — System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)

# KYA · System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)

_Obstetrics/Gynecology · 21 CFR 884.2982 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA

## Overview

- **Product Code:** KYA
- **Device Name:** System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
- **Regulation:** [21 CFR 884.2982](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2982)
- **Device Class:** 1
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

A nonelectrically powered or an AC-powered liquid crystal thermographic system intended for use as an adjunct to physical palpation or mammography in diagnostic screening for detection of breast cancer or other uses is a nonelectrically powered or an AC-powered device applied to the skin that displays the color patterns of heat sensitive cholesteric liquid crystals that respond to temperature variations of the surface of the body. This generic type of device may include patient and equipment supports, a means to ensure thermal contact between the patient's skin and the liquid crystals, component parts, and accessories.

## Classification Rationale

Class I (general controls).

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K900404](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA/K900404.md) | VARICOSCREEN(TM) | Promedex, Inc. | Dec 7, 1990 | SESE |
| [K832989](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA/K832989.md) | BREAST THERMAL ACTIVITY INDICATOR | Bcsi Laboratories, Inc. | Jan 17, 1984 | SESE |
| [K823245](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA/K823245.md) | THERMAX; THERMAX SYSTEM | American Thermometer Company, Inc. | Nov 16, 1982 | SESE |
| [K821524](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA/K821524.md) | CHIROPRATIC INFRA-RED CRYSTAL PAK | Dr. John D. Reid B.A., D.C. | Sep 8, 1982 | SESE |
| [K821049](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA/K821049.md) | PARATHERM | American Thermometer Company, Inc. | Apr 29, 1982 | SESE |

## Top Applicants

- American Thermometer Company, Inc. — 2 clearances
- Bcsi Laboratories, Inc. — 1 clearance
- Dr. John D. Reid B.A., D.C. — 1 clearance
- Promedex, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/KYA)

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