IZO · Generator, High-Voltage, X-Ray, Diagnostic
Radiology · 21 CFR 892.1700 · Class 1
Overview
| Product Code | IZO |
|---|---|
| Device Name | Generator, High-Voltage, X-Ray, Diagnostic |
| Regulation | 21 CFR 892.1700 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 163)
Showing 20 most recent of 163 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954666 | MPH50, MPH65, AND MPH80 | GE Medical Systems | Nov 24, 1995 | SESE |
| K953582 | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | Varian Canada, Inc. | Sep 26, 1995 | SESE |
| K953831 | N 800 HF | Nucletron-Oldelft Corp. | Sep 8, 1995 | SESE |
| K952822 | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | Shimadzu Corp. | Jul 12, 1995 | SESE |
| K952265 | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | Control-X, Inc. | Jul 6, 1995 | SESE |
| K950883 | POLYDOROS SX 65 AND 80 | Siemens Medical Solutions USA, Inc. | Apr 3, 1995 | SESE |
| K950694 | COMPACT-X | Electromed Intl., Ltd. | Mar 31, 1995 | SESE |
| K950291 | DIGITAL 625HF | Fischer Imaging Corp. | Mar 23, 1995 | SESE |
| K950041 | SII 360 APR | Scott Imaging Intl., Inc. | Mar 21, 1995 | SESE |
| K950040 | SII 525 APR | Scott Imaging Intl., Inc. | Mar 21, 1995 | SESE |
| K945453 | UD 150L-R II | Shimadzu Medical Systems | Mar 21, 1995 | SESE |
| K945452 | UD 150L-F | Shimadzu Medical Systems | Mar 21, 1995 | SESE |
| K950037 | N 800 HF | Oldelft Corp. of America | Feb 15, 1995 | SESE |
| K945731 | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | Bennett X-Ray Corp. | Feb 15, 1995 | SESE |
| K945668 | KXO-80G | Toshiba America Medical Systems, In.C | Dec 27, 1994 | SESE |
| K942731 | SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR | Shimadzu Corp. | Oct 13, 1994 | SESE |
| K944150 | MICRO X-65 HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE |
| K944149 | MICRO X-80 HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE |
| K944148 | MICRO X-30HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE |
| K944147 | MICRO X-50 HF | Fischer Imaging Corp. | Sep 16, 1994 | SESE |
Top Applicants
- Fischer Imaging Corp. — 22 clearances
- General Electric Co. — 12 clearances
- Shimadzu Medical Systems — 10 clearances
- Electromed Intl., Ltd. — 8 clearances
- Siemens Corp. — 6 clearances
