IZO — Generator, High-Voltage, X-Ray, Diagnostic Class I
FDA product code IZO covers "Generator, High-Voltage, X-Ray, Diagnostic", a Class I medical device regulated under 21 CFR 892.1700. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IZO
- Device Class
- Class I
- Regulation Number
- 892.1700
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K954666 | ge medical systems | MPH50, MPH65, AND MPH80 | November 24, 1995 |
| K953582 | varian canada | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | September 26, 1995 |
| K953831 | nucletron-oldelft | N 800 HF | September 8, 1995 |
| K952822 | shimadzu | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | July 12, 1995 |
| K952265 | control-x | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- | July 6, 1995 |
| K950883 | siemens medical solutions usa | POLYDOROS SX 65 AND 80 | April 3, 1995 |
| K950694 | electromed intl | COMPACT-X | March 31, 1995 |
| K950291 | fischer imaging | DIGITAL 625HF | March 23, 1995 |
| K950040 | scott imaging intl | SII 525 APR | March 21, 1995 |
| K945453 | shimadzu medical systems | UD 150L-R II | March 21, 1995 |
| K945452 | shimadzu medical systems | UD 150L-F | March 21, 1995 |
| K950041 | scott imaging intl | SII 360 APR | March 21, 1995 |
| K950037 | oldelft corp. of america | N 800 HF | February 15, 1995 |
| K945731 | bennett x-ray | HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS | February 15, 1995 |
| K945668 | toshiba america medical systems, in.c | KXO-80G | December 27, 1994 |
| K942731 | shimadzu | SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR | October 13, 1994 |
| K944149 | fischer imaging | MICRO X-80 HF | September 16, 1994 |
| K944150 | fischer imaging | MICRO X-65 HF | September 16, 1994 |
| K944148 | fischer imaging | MICRO X-30HF | September 16, 1994 |
| K944147 | fischer imaging | MICRO X-50 HF | September 16, 1994 |