OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)
Device Facts
| Record ID | K951806 |
|---|---|
| Device Name | OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) |
| Applicant | Opgal Optronic Industries |
| Product Code | LHQ · Obstetrics/Gynecology |
| Decision Date | Jul 6, 1995 |
| 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.
