IZF
- Product code
- IZF
- Device name
- System, X-Ray, Tomographic
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1740
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 42 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252649 | 2026-02-02 | Nano-X Imaging , Ltd. | TAP2D | |
| K252133 | 2025-11-06 | Adaptix Limited | Adaptix Ortho350 | |
| K250850 | 2025-04-16 | Nano-X Imaging , Ltd. | Nanox.ARC X | |
| K242395 | 2024-12-04 | Nano-X Imaging , Ltd. | Nanox.ARC |
Official FDA classification page: IZF
Classification and pathway per current FDA publications. Data from openFDA (CC0).