3T Neck Matrix MR Coil kit
Model 08626561 · Siemens Healthcare GmbH · DI 04056869014425
LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000
UDILibrary device dossier · generated 2026-09-08 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
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) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.5 |
| 2019-04 | 0 | 2.75 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 2 |
| 2019-10 | 0 | 1.4 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-07 | 0 | 1.6 |
| 2020-08 | 0 | 4 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-12 | 0 | 1.5 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.33 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 0 | 1.13 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.33 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1.25 |
| 2022-10 | 0 | 1.17 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.33 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1.33 |
| 2023-03 | 0 | 2.9 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1.9 |
| 2023-06 | 0 | 1.5 |
| 2023-07 | 0 | 1.38 |
| 2023-08 | 0 | 2.17 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.57 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 1.2 |
| 2024-01 | 0 | 1.2 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.33 |
| 2024-08 | 0 | 1.5 |
| 2024-09 | 0 | 1.17 |
| 2024-10 | 0 | 1.33 |
| 2024-11 | 0 | 1.78 |
| 2024-12 | 0 | 1.21 |
| 2025-01 | 0 | 4.86 |
| 2025-02 | 0 | 3.38 |
| 2025-03 | 0 | 2.36 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.35 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 5.64 |
| 2025-08 | 0 | 7.95 |
| 2025-09 | 0 | 4.53 |
| 2025-10 | 0 | 5.21 |
| 2025-11 | 0 | 4.11 |
| 2025-12 | 0 | 7.12 |
| 2026-01 | 0 | 5.95 |
| 2026-02 | 0 | 3.8 |
| 2026-03 | 0 | 3.48 |
| 2026-04 | 0 | 3.97 |
| 2026-05 | 0 | 6.61 |
| 2026-06 | 0 | 3.1 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K121434 — cites (transitively): K082427 (d1), K091114 (d1), K103274 (d1), K053042 (d2) — cited as predicate by K123510, K123920, K123938, K130262, K130749, K132831, K132951, K133692, K140666, K141977, K143020, K152602, K163234, K170396, K170840, K181613, K191050, K220018
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Siemens Healthcare GmbH
- NAI 2014-09-25 Siemens AG/Siemens Healthcare GmbH · 0 citations
- VAI 2011-06-09 Siemens Healthcare GmbH · 1 citations
- NAI 2010-09-14 Siemens AG/Siemens Healthcare GmbH · 0 citations