KPZ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Generator, High Voltage, X-Ray, Therapeutic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5900
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PATIENT DOSE MONITOR (K912249) | Theta Systems, Inc. | 1991-08-30 |
| 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS (K860469) | Victoreen, Inc. | 1986-04-16 |
| VERIFLEX (K854410) | Old Delft Corp. of America | 1986-02-12 |
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Every clearance here is in the API, with alerts when new ones post.