FDA product code ITZ: Assembly, Tube Housing, X-Ray, Therapeutic
ITZ is the FDA product code for assembly, tube housing, x-ray, therapeutic. It is a Class II device, regulated under 21 CFR 892.5930 and reviewed by the Radiology panel. Devices under ITZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Assembly, Tube Housing, X-Ray, Therapeutic |
| Device class | Class II |
| Regulation | 21 CFR 892.5930 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for ITZ devices
openFDA lists no recalls for product code ITZ.
Frequently asked questions
What is FDA product code ITZ?
ITZ is the FDA product code for assembly, tube housing, x-ray, therapeutic. It is a Class II device, regulated under 21 CFR 892.5930 and reviewed by the Radiology panel.
What device class is ITZ?
Class II, regulation 21 CFR 892.5930. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code ITZ
- Run a recall and safety report across every ITZ manufacturer
- Watch product code ITZ 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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