IYM · System, Telethermographic, Infrared
Obstetrics/Gynecology · 21 CFR 884.2980 · Class 3
Overview
| Product Code | IYM |
|---|---|
| Device Name | System, Telethermographic, Infrared |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863736 | FMS MODEL 110 | Flir Medical Systems | Dec 29, 1986 | SN |
| K852950 | VISITHERM | C.D. Regelin & Associates, Inc. | Feb 7, 1986 | SESE |
| K823041 | JEOL MODEL #JTG-500M | Jeol | Nov 24, 1982 | SESE |
| K812799 | DCATS | Dorex, Inc. | Oct 20, 1981 | SESE |
| K812701 | ORTHO-THERM INFRARED SENSOR | Orthion Corp. | Oct 13, 1981 | SESE |
| K801553 | THERMOCOMP | Hospital Financial Corp. | Oct 31, 1980 | SESE |
| K800491 | GRAPHIC STRESS TELETHERMOMETRY | Gst Laboratories of Ca, Inc. | Mar 4, 1980 | SESP |
| K760999 | THERMOGRAPH, MEDICAL | Honeywell, Inc. | Nov 19, 1976 | SESE |
Top Applicants
- C.D. Regelin & Associates, Inc. — 1 clearance
- Dorex, Inc. — 1 clearance
- Flir Medical Systems — 1 clearance
- Gst Laboratories of Ca, Inc. — 1 clearance
- Honeywell, Inc. — 1 clearance
