FDA product code IZL: System, X-Ray, Mobile
IZL is the FDA product code for system, x-ray, mobile. It is a Class II device, regulated under 21 CFR 892.1720 and reviewed by the Radiology panel. FDA has cleared 237 510(k) submissions under IZL, 44 in the last five years, from 124 different applicants. The average 510(k) review took 87 days (median 59); 173 days on average over the last three years. FDA has posted 170 recalls for IZL devices, 80 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Mobile |
| Device class | Class II |
| Regulation | 21 CFR 892.1720 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IZL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 61 |
| 2018 | 8 | 57 |
| 2019 | 9 | 67 |
| 2020 | 9 | 66 |
| 2021 | 13 | 55 |
| 2022 | 16 | 98 |
| 2023 | 3 | 83 |
| 2024 | 9 | 143 |
| 2025 | 11 | 197 |
| 2026 | 5 | 179 |
Compare with all 510(k) review times · Search every IZL clearance
Top IZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sedecal., Sa. | 17 | 2023-08-21 |
| Minxray, Inc. | 15 | 2021-03-19 |
| General X-Ray, Inc. | 11 | 1979-03-28 |
| Samsung Electronics Co., Ltd. | 8 | 2024-10-01 |
| DRGEM Corporation | 6 | 2026-05-14 |
119 more applicants have IZL clearances. See the full list in Caduvo.
Most recent IZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260236 | GEMSS HEALTHCARE CO., LTD. | XLITE | 2026-08-03 | 189 |
| K253058 | Shantou Institute of Ultrasonic Instruments Co., Ltd. | Portable DR Imaging System | 2026-06-18 | 269 |
| K260085 | DRGEM Corporation | RAYMO Mobile X-ray System (Model: RAYMO) | 2026-05-14 | 122 |
| K253185 | Carestream Health | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | 2026-03-11 | 166 |
| K253244 | Poskom Co., Ltd. | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | 2026-02-23 | 147 |
Recalls for IZL devices
170 product recalls in 91 recall events; 80 initiated in the last five years and 81 still open. Most recent: 2026-06-05.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 4 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 12 |
| 2024 | 10 |
| 2025 | 51 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code IZL?
IZL is the FDA product code for system, x-ray, mobile. It is a Class II device, regulated under 21 CFR 892.1720 and reviewed by the Radiology panel.
What device class is IZL?
Class II, regulation 21 CFR 892.1720. Typical premarket route: 510(k).
How long does a 510(k) take for product code IZL?
Across 237 cleared submissions the average was 87 days from receipt to decision (median 59).
Which companies have the most IZL clearances?
Sedecal., Sa. (17); Minxray, Inc. (15); General X-Ray, Inc. (11); Samsung Electronics Co., Ltd. (8); DRGEM Corporation (6).
Have IZL devices been recalled?
Yes: 170 product recalls across 91 recall events; the most recent began 2026-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code IZL
- Run a recall and safety report across every IZL manufacturer
- Watch product code IZL 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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