System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
The Nonpowered Liquid Crystal Thermographic System for Adjunctive Use is a passive imaging device that uses liquid crystal materials to visualize skin temperature distribution without an external power source, intended only as an adjunct to other diagnostic modalities in conditions such as breast assessment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KYA, regulated under 21 CFR 884.2982, in the Obstetrics/Gynecology medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- KYA
- Device Class
- FDA class 1
- Regulation Number
- 884.2982
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900404 | VARICOSCREEN(TM) | Dec 07, 1990 | Substantially Equivalent | PROMEDEX, INC. |
| K832989 | BREAST THERMAL ACTIVITY INDICATOR | Jan 17, 1984 | Substantially Equivalent | BCSI LABORATORIES, INC. |
| K823245 | THERMAX; THERMAX SYSTEM | Nov 16, 1982 | Substantially Equivalent | AMERICAN THERMOMETER COMPANY, INC. |
| K821524 | CHIROPRATIC INFRA-RED CRYSTAL PAK | Sep 08, 1982 | Substantially Equivalent | DR. JOHN D. REID B.A., D.C. |
| K821049 | PARATHERM | Apr 29, 1982 | Substantially Equivalent | AMERICAN THERMOMETER COMPANY, INC. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.