System, Telethermographic, Infrared
An infrared telethermographic system is a device that captures and displays thermal radiation patterns emitted from the body surface, used in obstetrics and gynecology for applications such as detecting vascular abnormalities or breast thermal asymmetry. It is classified as FDA Class 3, the highest risk category, meaning it requires Premarket Approval (PMA) demonstrating safety and effectiveness before it can be marketed. The product code is IYM, regulated under 21 CFR 884.2980, within the Obstetrics/Gynecology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- IYM
- Device Class
- FDA class 3
- Regulation Number
- 884.2980
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- RA
- Submission Type
- 2
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863736 | FMS MODEL 110 | Dec 29, 1986 | Substantially Equivalent for Some Indications | Flir Medical Systems |
| K852950 | VISITHERM | Feb 07, 1986 | Substantially Equivalent | C.D. Regelin & Associates, Inc. |
| K823041 | JEOL MODEL #JTG-500M | Nov 24, 1982 | Substantially Equivalent | Jeol |
| K812799 | DCATS | Oct 20, 1981 | Substantially Equivalent | Dorex, Inc. |
| K812701 | ORTHO-THERM INFRARED SENSOR | Oct 13, 1981 | Substantially Equivalent | Orthion Corp. |
| K801553 | THERMOCOMP | Oct 31, 1980 | Substantially Equivalent | Hospital Financial Corp. |
| K800491 | GRAPHIC STRESS TELETHERMOMETRY | Mar 04, 1980 | Unknown | Gst Laboratories of Ca, Inc. |
| K760999 | THERMOGRAPH, MEDICAL | Nov 19, 1976 | Substantially Equivalent | Honeywell, Inc. |