Product Code: KPZ
FDA class 2
21 CFR 892.5900
Generator, High Voltage, X-Ray, Therapeutic
Radiology
This device is a high voltage generator used in x-ray therapy units to produce the high-energy electrical power required for therapeutic x-ray beam generation in radiation oncology applications. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPZ, regulated under 21 CFR 892.5900 within the Radiology specialty. This device is eligible for third-party review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
6
Basic Information
- Product Code
- KPZ
- Device Class
- FDA class 2
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K912249 | PATIENT DOSE MONITOR | Aug 30, 1991 | Substantially Equivalent | Theta Systems, Inc. |
| K860469 | 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS | Apr 16, 1986 | Substantially Equivalent | Victoreen, Inc. |
| K854410 | VERIFLEX | Feb 12, 1986 | Substantially Equivalent | Old Delft Corp. of America |