FDA product code IZF: System, X-Ray, Tomographic
IZF is the FDA product code for system, x-ray, tomographic. It is a Class II device, regulated under 21 CFR 892.1740 and reviewed by the Radiology panel. FDA has cleared 42 510(k) submissions under IZF, 6 in the last five years, from 29 different applicants. The average 510(k) review took 85 days (median 59); 117 days on average over the last three years. FDA has posted 6 recalls for IZF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Tomographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1740 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IZF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 70 |
| 2020 | 1 | 104 |
| 2021 | 1 | 33 |
| 2023 | 2 | 210 |
| 2024 | 1 | 113 |
| 2025 | 2 | 74 |
| 2026 | 1 | 165 |
Compare with all 510(k) review times · Search every IZF clearance
Top IZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nano-X Imaging , Ltd. | 4 | 2026-02-02 |
| Siemens Corp. | 4 | 1981-06-23 |
| Agfa N.V. | 2 | 2020-03-09 |
| Pausch Corp. | 2 | 1998-06-17 |
| Continental X-Ray Corp. | 2 | 1995-03-31 |
24 more applicants have IZF clearances. See the full list in Caduvo.
Most recent IZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252649 | Nano-X Imaging , Ltd. | TAP2D | 2026-02-02 | 165 |
| K252133 | Adaptix Limited | Adaptix Ortho350 | 2025-11-06 | 122 |
| K250850 | Nano-X Imaging , Ltd. | Nanox.ARC X | 2025-04-16 | 27 |
| K242395 | Nano-X Imaging , Ltd. | Nanox.ARC | 2024-12-04 | 113 |
| K222934 | Nano-X Imaging , Ltd. | Nanox.ARC | 2023-04-28 | 214 |
Recalls for IZF devices
6 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-18.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IZF?
IZF is the FDA product code for system, x-ray, tomographic. It is a Class II device, regulated under 21 CFR 892.1740 and reviewed by the Radiology panel.
What device class is IZF?
Class II, regulation 21 CFR 892.1740. Typical premarket route: 510(k).
How long does a 510(k) take for product code IZF?
Across 42 cleared submissions the average was 85 days from receipt to decision (median 59).
Which companies have the most IZF clearances?
Nano-X Imaging , Ltd. (4); Siemens Corp. (4); Agfa N.V. (2); Pausch Corp. (2); Continental X-Ray Corp. (2).
Have IZF devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2025-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code IZF
- Run a recall and safety report across every IZF manufacturer
- Watch product code IZF 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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