KXZ · System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Obstetrics/Gynecology · 21 CFR 884.2982 · Class 3
Overview
| Product Code | KXZ |
|---|---|
| Device Name | System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) |
| Regulation | 21 CFR 884.2982 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K851034 | NOVATHERM | Medtech Products, Inc. | Sep 27, 1985 | SESE |
| K843124 | Q-SCAN THERMOGRAPHY SYSTEM | Qmax Medical, Inc. | Nov 29, 1984 | SESE |
| K832731 | BREAST & BODY HEALTH SYSTEM 2000 | American Thermal Instruments, Inc. | Jan 30, 1984 | SESE |
| K813547 | THERMASCAN | Bcd Products, Inc. | Mar 12, 1982 | SESE |
| K781916 | FLEXT-THERM | E-Z-Em, Inc. | Feb 2, 1979 | SESE |
| K770986 | FLEXI-THERM FILM | E-Z-Em, Inc. | Sep 12, 1977 | SESE |
| K770678 | ELC-THERMO-SYSTEM | Cutter Laboratories, Inc. | May 25, 1977 | SESE |
Top Applicants
- E-Z-Em, Inc. — 2 clearances
- American Thermal Instruments, Inc. — 1 clearance
- Bcd Products, Inc. — 1 clearance
- Cutter Laboratories, Inc. — 1 clearance
- Medtech Products, Inc. — 1 clearance
