System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
FDA product code KXZ · Class III (high risk) · 21 CFR 884.2982 · Obstetrics/Gynecology
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851034 | NovathermKXZ · Traditional | Medtech Products, Inc. | 09/27/1985SE |
| K843124 | Q-Scan Thermography SystemKXZ · Traditional | Qmax Medical, Inc. | 11/29/1984SE |
| K832731 | Breast & Body Health System 2000KXZ · Traditional | American Thermal Instruments, Inc. | 01/30/1984SE |
| K813547 | ThermascanKXZ · Traditional | Bcd Products, Inc. | 03/12/1982SE |
| K781916 | Flext-ThermKXZ · Traditional | E-Z-Em, Inc. | 02/02/1979SE |
| K770986 | Flexi-Therm FilmKXZ · Traditional | E-Z-Em, Inc. | 09/12/1977SE |
| K770678 | Elc-Thermo-SystemKXZ · Traditional | Cutter Laboratories, Inc. | 05/25/1977SE |