SEDECAL
Model AeroDR TX m01 · SEDECAL · DI 08436046003125
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 2026-09-14 · 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 |
|---|---|---|---|---|---|
| 2023-02-06 | Z-1203-2023 | Class II | Open, Classified | Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. | k number procode |
Adverse-event reports — MAUDE (0)
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.
| 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 | 0 | 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
- K221803 SESE 2022-07-18 (k number procode)
Predicate lineage
K221803 — cites (transitively): K151465 (d1), K172793 (d1), K210619 (d1), K212291 (d1), K102349 (d2), K141271 (d2), K162504 (d2), K182688 (d2), K192011 (d2), K113248 (d3), K120477 (d3), K130936 (d3), K131106 (d3), K133693 (d3), K161345 (d3), K170332 (d3), K171270 (d3), K190368 (d3), K103591 (d4), K101517 (d4), K153312 (d4), K102012 (d5), K111682 (d5), K112309 (d5), K140771 (d5), K063781 (d6), K093355 (d6), K964124 (d7) — cited as predicate by K223267
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