FDA product code IZT: Cone, Radiographic
IZT is the FDA product code for cone, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IZT. The average 510(k) review took 77 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Cone, Radiographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1610 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IZT clearance
Top IZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Denar Corp. | 1 | 1992-12-09 |
Most recent IZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924759 | Denar Corp. | COLLIMATOR LIGHT SOURCE | 1992-12-09 | 77 |
Recalls for IZT devices
openFDA lists no recalls for product code IZT.
Frequently asked questions
What is FDA product code IZT?
IZT is the FDA product code for cone, radiographic. It is a Class II device, regulated under 21 CFR 892.1610 and reviewed by the Radiology panel.
What device class is IZT?
Class II, regulation 21 CFR 892.1610. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZT?
Across 1 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most IZT clearances?
Denar Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IZT
- Run a recall and safety report across every IZT manufacturer
- Watch product code IZT 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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