21 CFR 884.2980 — System, Telethermographic, Infrared
Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2980
Identification
A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class I (general controls) for the adjunctive diagnostic screening system; Class III for the system intended for use alone in diagnostic screening.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IYM | System, Telethermographic, Infrared | 3 | 8 | |
| LHP | System, Telethermographic (Sole Diagnostic Screen) | 3 | 0 | |
| LHQ | System, Telethermographic (Adjunctive Use) | 1 | 40 |
