System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
The Powered Liquid Crystal Thermographic System for Adjunctive Use is an imaging device that uses liquid crystal technology with an electrical power source to map skin surface temperature patterns, intended for use alongside other diagnostic methods in assessing conditions such as breast pathology. It is classified as FDA Class 3, the highest risk level, requiring Premarket Approval (PMA) before marketing. The product code is KXZ, regulated under 21 CFR 884.2982, in the Obstetrics/Gynecology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KXZ
- Device Class
- FDA class 3
- Regulation Number
- 884.2982
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K851034 | NOVATHERM | Sep 27, 1985 | Substantially Equivalent | Medtech Products, Inc. |
| K843124 | Q-SCAN THERMOGRAPHY SYSTEM | Nov 29, 1984 | Substantially Equivalent | Qmax Medical, Inc. |
| K832731 | BREAST & BODY HEALTH SYSTEM 2000 | Jan 30, 1984 | Substantially Equivalent | American Thermal Instruments, Inc. |
| K813547 | THERMASCAN | Mar 12, 1982 | Substantially Equivalent | Bcd Products, Inc. |
| K781916 | FLEXT-THERM | Feb 02, 1979 | Substantially Equivalent | E-Z-Em, Inc. |
| K770986 | FLEXI-THERM FILM | Sep 12, 1977 | Substantially Equivalent | E-Z-Em, Inc. |
| K770678 | ELC-THERMO-SYSTEM | May 25, 1977 | Substantially Equivalent | Cutter Laboratories, Inc. |