CRT2000 THERMOGRAPHIC SYSTEM
Device Facts
| Record ID | K971956 |
|---|---|
| Device Name | CRT2000 THERMOGRAPHIC SYSTEM |
| Applicant | Werner Eidam Medizin-Technologie GmbH |
| Product Code | LHQ · Obstetrics/Gynecology |
| Decision Date | Aug 22, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2980 |
| Device Class | Class 1 |
Regulatory Classification
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.
