SEDECAL
Model Soltus 450 · SEDECAL · DI 08436046002531
IZL — System, X-Ray, Mobile · Class II · 21 CFR 892.1720
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) · Class II · 21 CFR 892.1680
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2022-08-12 | Z-0182-2023 | Class II | Open, Classified | Due to un-commanded movement of mobile x-ray unit. | code info di |
Adverse-event reports — MAUDE (1)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 2 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 1.5 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 0 | 1 |
| 2019-12 | 0 | 3.5 |
| 2020-01 | 0 | 1.33 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-04 | 0 | 1.67 |
| 2020-06 | 0 | 2 |
| 2020-08 | 0 | 1.5 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 2 |
| 2020-12 | 0 | 2.25 |
| 2021-01 | 0 | 2.75 |
| 2021-02 | 0 | 1.67 |
| 2021-03 | 0 | 1.67 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 1.29 |
| 2021-06 | 0 | 1.5 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1.25 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 1.33 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 3 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.5 |
| 2022-05 | 0 | 1.75 |
| 2022-06 | 0 | 1.38 |
| 2022-07 | 0 | 6 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 3.5 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 2.33 |
| 2023-02 | 0 | 1.5 |
| 2023-03 | 0 | 2.25 |
| 2023-04 | 1 | 1.82 |
| 2023-05 | 0 | 1.8 |
| 2023-06 | 0 | 4.43 |
| 2023-07 | 0 | 2.75 |
| 2023-08 | 0 | 1.86 |
| 2023-09 | 0 | 2.67 |
| 2023-10 | 0 | 2.33 |
| 2023-11 | 0 | 2.33 |
| 2023-12 | 0 | 2.67 |
| 2024-01 | 0 | 3.5 |
| 2024-02 | 0 | 2.25 |
| 2024-03 | 0 | 3 |
| 2024-04 | 0 | 5.4 |
| 2024-05 | 0 | 2.6 |
| 2024-06 | 0 | 1.14 |
| 2024-07 | 0 | 2 |
| 2024-08 | 0 | 2.14 |
| 2024-09 | 0 | 3.25 |
| 2024-10 | 0 | 4.5 |
| 2024-11 | 0 | 3.75 |
| 2024-12 | 0 | 2.33 |
| 2025-01 | 0 | 3.8 |
| 2025-02 | 0 | 5 |
| 2025-03 | 0 | 2.56 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.83 |
| 2025-06 | 0 | 2.67 |
| 2025-07 | 0 | 3 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 1.33 |
| 2025-11 | 0 | 2.73 |
| 2025-12 | 0 | 4.25 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 2.95 |
| 2026-03 | 0 | 2.2 |
| 2026-04 | 0 | 2.59 |
| 2026-05 | 0 | 2.28 |
| 2026-06 | 0 | 4.23 |
Regulatory clearances
- K192936 SESE 2019-11-15 (k number procode)
Predicate lineage
K192936 — cites (transitively): K131106 (d1), K133693 (d1), K170332 (d1), K171270 (d1), K190368 (d1), K192011 (d1), K103591 (d2), K153312 (d2), K161345 (d2), K102012 (d3), K111682 (d3), K112309 (d3), K140771 (d3), K101517 (d3), K063781 (d4), K093355 (d4), K964124 (d5)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SEDECAL
- OAI 2025-01-24 SEDECAL SA · 4 citations
- VAI 2013-06-28 SEDECAL SA · 2 citations
- NAI 2010-01-15 SEDECAL SA · 0 citations