FDA product code LLZ: System, Image Processing, Radiological
LLZ is the FDA product code for system, image processing, radiological. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 2,290 510(k) submissions under LLZ, 312 in the last five years, from 1,045 different applicants. The average 510(k) review took 106 days (median 78); 149 days on average over the last three years. FDA has posted 560 recalls for LLZ devices, 98 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Image Processing, Radiological |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LLZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 78 | 117 |
| 2018 | 104 | 151 |
| 2019 | 74 | 118 |
| 2020 | 81 | 132 |
| 2021 | 83 | 145 |
| 2022 | 65 | 151 |
| 2023 | 87 | 189 |
| 2024 | 62 | 148 |
| 2025 | 58 | 180 |
| 2026 | 40 | 120 |
Compare with all 510(k) review times · Search every LLZ clearance
Top LLZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 74 | 2024-10-11 |
| Totoku Electric Co., Ltd. | 40 | 2011-12-23 |
| Barco N.V. | 37 | 2014-03-28 |
| Vital Images, Inc. | 34 | 2018-11-20 |
| Eizo Nanao Corporation | 34 | 2013-03-28 |
1,040 more applicants have LLZ clearances. See the full list in Caduvo.
Most recent LLZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261855 | Elucid Bioimaging, Inc. | Elucid PlaqueIQ | 2026-09-18 | 107 |
| K254214 | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | OOOPDS | 2026-09-15 | 260 |
| K261861 | Mdsim S.A. | SPINEsim v1.0 | 2026-09-15 | 103 |
| K262060 | Radiopharmaceutical Imaging & Dosimetry, LLC | 3D-RD-S | 2026-09-04 | 78 |
| K261500 | S.M.A.I.O | KBA3D (v2.4.0) | 2026-08-17 | 103 |
Recalls for LLZ devices
560 product recalls in 432 recall events; 98 initiated in the last five years and 104 still open. Most recent: 2026-07-31.
| Year | Recalls |
|---|---|
| 2017 | 18 |
| 2018 | 21 |
| 2019 | 12 |
| 2020 | 13 |
| 2021 | 12 |
| 2022 | 14 |
| 2023 | 14 |
| 2024 | 20 |
| 2025 | 29 |
| 2026 | 19 |
Frequently asked questions
What is FDA product code LLZ?
LLZ is the FDA product code for system, image processing, radiological. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is LLZ?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLZ?
Across 2,290 cleared submissions the average was 106 days from receipt to decision (median 78).
Which companies have the most LLZ clearances?
Siemens Medical Solutions USA, Inc. (74); Totoku Electric Co., Ltd. (40); Barco N.V. (37); Vital Images, Inc. (34); Eizo Nanao Corporation (34).
Have LLZ devices been recalled?
Yes: 560 product recalls across 432 recall events; the most recent began 2026-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code LLZ
- Run a recall and safety report across every LLZ manufacturer
- Watch product code LLZ 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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