KPZ · Generator, High Voltage, X-Ray, Therapeutic
Radiology · 21 CFR 892.5900 · Class 2
Overview
| Product Code | KPZ |
|---|---|
| Device Name | Generator, High Voltage, X-Ray, Therapeutic |
| Regulation | 21 CFR 892.5900 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K912249 | PATIENT DOSE MONITOR | Theta Systems, Inc. | Aug 30, 1991 | SESE |
| K860469 | 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS | Victoreen, Inc. | Apr 16, 1986 | SESE |
| K854410 | VERIFLEX | Old Delft Corp. of America | Feb 12, 1986 | SESE |
Top Applicants
- Victoreen, Inc. — 1 clearance
- Theta Systems, Inc. — 1 clearance
- Old Delft Corp. of America — 1 clearance
