FDA product code KXZ: System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
KXZ is the FDA product code for system, thermographic, liquid crystal, powered (adjunctive use). It is a Class III device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel. FDA has cleared 7 510(k) submissions under KXZ, from 6 different applicants. The average 510(k) review took 114 days (median 104).
Classification
| Field | Value |
|---|---|
| Device name | System, Thermographic, Liquid Crystal, Powered (Adjunctive Use) |
| Device class | Class III |
| Regulation | 21 CFR 884.2982 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Compare with all 510(k) review times · Search every KXZ clearance
Top KXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E-Z-Em, Inc. | 2 | 1979-02-02 |
| Medtech Products, Inc. | 1 | 1985-09-27 |
| Qmax Medical, Inc. | 1 | 1984-11-29 |
| American Thermal Instruments, Inc. | 1 | 1984-01-30 |
| Bcd Products, Inc. | 1 | 1982-03-12 |
1 more applicants have KXZ clearances. See the full list in Caduvo.
Most recent KXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851034 | Medtech Products, Inc. | NOVATHERM | 1985-09-27 | 198 |
| K843124 | Qmax Medical, Inc. | Q-SCAN THERMOGRAPHY SYSTEM | 1984-11-29 | 113 |
| K832731 | American Thermal Instruments, Inc. | BREAST & BODY HEALTH SYSTEM 2000 | 1984-01-30 | 179 |
| K813547 | Bcd Products, Inc. | THERMASCAN | 1982-03-12 | 81 |
| K781916 | E-Z-Em, Inc. | FLEXT-THERM | 1979-02-02 | 80 |
Recalls for KXZ devices
openFDA lists no recalls for product code KXZ.
Frequently asked questions
What is FDA product code KXZ?
KXZ is the FDA product code for system, thermographic, liquid crystal, powered (adjunctive use). It is a Class III device, regulated under 21 CFR 884.2982 and reviewed by the Radiology panel.
What device class is KXZ?
Class III, regulation 21 CFR 884.2982. Typical premarket route: PMA.
How long does a 510(k) take for product code KXZ?
Across 7 cleared submissions the average was 114 days from receipt to decision (median 104).
Which companies have the most KXZ clearances?
E-Z-Em, Inc. (2); Medtech Products, Inc. (1); Qmax Medical, Inc. (1); American Thermal Instruments, Inc. (1); Bcd Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KXZ
- Run a recall and safety report across every KXZ manufacturer
- Watch product code KXZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times