21 CFR 884.2982 — System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2982
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KXZ | System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) | 3 | 7 | |
| KYA | System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use) | 1 | 5 | |
| LHM | System, Thermographic, Liquid Crystal | 1 | 1 | |
| LHR | System, Thermographic, Liquid Crystal (Sole Diagnostic Screen) | 3 | 0 |
