FDA product code IZO: Generator, High-Voltage, X-Ray, Diagnostic
IZO is the FDA product code for generator, high-voltage, x-ray, diagnostic. It is a Class I device, regulated under 21 CFR 892.1700 and reviewed by the Radiology panel. FDA has cleared 163 510(k) submissions under IZO, from 58 different applicants. The average 510(k) review took 75 days (median 60). FDA has posted 4 recalls for IZO devices.
Classification
| Field | Value |
|---|---|
| Device name | Generator, High-Voltage, X-Ray, Diagnostic |
| Device class | Class I |
| Regulation | 21 CFR 892.1700 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IZO clearance
Top IZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fischer Imaging Corp. | 22 | 1995-03-23 |
| General Electric Co. | 12 | 1994-04-28 |
| Shimadzu Medical Systems | 10 | 1995-03-21 |
| Electromed Intl., Ltd. | 8 | 1995-03-31 |
| Siemens Corp. | 6 | 1982-02-24 |
53 more applicants have IZO clearances. See the full list in Caduvo.
Most recent IZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954666 | GE Medical Systems | MPH50, MPH65, AND MPH80 | 1995-11-24 | 45 |
| K953582 | Varian Canada, Inc. | HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR | 1995-09-26 | 56 |
| K953831 | Nucletron-Oldelft Corp. | N 800 HF | 1995-09-08 | 24 |
| K952822 | Shimadzu Corp. | SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G | 1995-07-12 | 22 |
| K952265 | Control-X, Inc. | MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR | 1995-07-06 | 52 |
Recalls for IZO devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-20.
Frequently asked questions
What is FDA product code IZO?
IZO is the FDA product code for generator, high-voltage, x-ray, diagnostic. It is a Class I device, regulated under 21 CFR 892.1700 and reviewed by the Radiology panel.
What device class is IZO?
Class I, regulation 21 CFR 892.1700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZO?
Across 163 cleared submissions the average was 75 days from receipt to decision (median 60).
Which companies have the most IZO clearances?
Fischer Imaging Corp. (22); General Electric Co. (12); Shimadzu Medical Systems (10); Electromed Intl., Ltd. (8); Siemens Corp. (6).
Have IZO devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2016-11-20.
Next steps
- Run an FDA pathway report with predicate devices for product code IZO
- Run a recall and safety report across every IZO manufacturer
- Watch product code IZO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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