FDA product code KPZ: Generator, High Voltage, X-Ray, Therapeutic
KPZ is the FDA product code for generator, high voltage, x-ray, therapeutic. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel. FDA has cleared 3 510(k) submissions under KPZ, from 3 different applicants. The average 510(k) review took 91 days (median 101).
Classification
| Field | Value |
|---|---|
| Device name | Generator, High Voltage, X-Ray, Therapeutic |
| Device class | Class II |
| Regulation | 21 CFR 892.5900 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KPZ clearance
Top KPZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Theta Systems, Inc. | 1 | 1991-08-30 |
| Victoreen, Inc. | 1 | 1986-04-16 |
| Old Delft Corp. of America | 1 | 1986-02-12 |
Most recent KPZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912249 | Theta Systems, Inc. | PATIENT DOSE MONITOR | 1991-08-30 | 101 |
| K860469 | Victoreen, Inc. | 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS | 1986-04-16 | 69 |
| K854410 | Old Delft Corp. of America | VERIFLEX | 1986-02-12 | 103 |
Recalls for KPZ devices
openFDA lists no recalls for product code KPZ.
Frequently asked questions
What is FDA product code KPZ?
KPZ is the FDA product code for generator, high voltage, x-ray, therapeutic. It is a Class II device, regulated under 21 CFR 892.5900 and reviewed by the Radiology panel.
What device class is KPZ?
Class II, regulation 21 CFR 892.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPZ?
Across 3 cleared submissions the average was 91 days from receipt to decision (median 101).
Which companies have the most KPZ clearances?
Theta Systems, Inc. (1); Victoreen, Inc. (1); Old Delft Corp. of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KPZ
- Run a recall and safety report across every KPZ manufacturer
- Watch product code KPZ 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.
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