LHP · System, Telethermographic (Sole Diagnostic Screen)
Obstetrics/Gynecology · 21 CFR 884.2980 · Class 3
Overview
| Product Code | LHP |
|---|---|
| Device Name | System, Telethermographic (Sole Diagnostic Screen) |
| Regulation | 21 CFR 884.2980 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
