Tx/Rx Knee 18 Coil 3T
Model 10840787 · Siemens Shenzhen Magnetic Resonance Ltd. · DI 04056869053431
LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000
LNI — System, Nuclear Magnetic Resonance Spectroscopic · Class II · 21 CFR 892.1000
MOS — Coil, Magnetic Resonance, Specialty · Class II · 21 CFR 892.1000
UDILibrary device dossier · generated 2026-09-06 · 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 | 2.29 |
| 2019-04 | 0 | 3.05 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 2.13 |
| 2019-10 | 0 | 1.42 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1.25 |
| 2020-07 | 0 | 1.69 |
| 2020-08 | 0 | 4 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-12 | 0 | 1.36 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 3 |
| 2021-05 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.29 |
| 2021-10 | 0 | 1.38 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1.43 |
| 2022-03 | 0 | 1.14 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.29 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1.33 |
| 2022-10 | 0 | 1.2 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.31 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1.25 |
| 2023-03 | 0 | 2.81 |
| 2023-04 | 0 | 1.57 |
| 2023-05 | 0 | 1.77 |
| 2023-06 | 0 | 1.43 |
| 2023-07 | 0 | 1.39 |
| 2023-08 | 0 | 2.33 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.79 |
| 2023-11 | 0 | 2.22 |
| 2023-12 | 0 | 1.17 |
| 2024-01 | 0 | 1.17 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.25 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.4 |
| 2024-08 | 0 | 1.69 |
| 2024-09 | 0 | 1.25 |
| 2024-10 | 0 | 1.33 |
| 2024-11 | 0 | 1.89 |
| 2024-12 | 0 | 1.22 |
| 2025-01 | 0 | 4.67 |
| 2025-02 | 0 | 3.29 |
| 2025-03 | 0 | 2.41 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.36 |
| 2025-06 | 0 | 4.95 |
| 2025-07 | 0 | 5.46 |
| 2025-08 | 0 | 7.53 |
| 2025-09 | 0 | 4.34 |
| 2025-10 | 0 | 5.1 |
| 2025-11 | 0 | 3.92 |
| 2025-12 | 0 | 7 |
| 2026-01 | 0 | 6.47 |
| 2026-02 | 0 | 3.8 |
| 2026-03 | 0 | 3.44 |
| 2026-04 | 0 | 3.62 |
| 2026-05 | 0 | 6.38 |
| 2026-06 | 0 | 3 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K170396 — cites (transitively): K121434 (d1), K123510 (d1), K141977 (d1), K150843 (d1), K153343 (d1), K162102 (d1), K163312 (d1), K082427 (d2), K091114 (d2), K103274 (d2), K073194 (d2), K090038 (d2), K121160 (d2), K121459 (d2), K132831 (d2), K132951 (d2), K133435 (d2), K140253 (d2), K140998 (d2), K151579 (d2), K151597 (d2), K053042 (d3), K072237 (d3), K092519 (d3), K130885 (d3), K132119 (d3), K050263 (d3), K143311 (d3), K101347 (d4), K123938 (d4), K041112 (d5) — cited as predicate by K173617, K181322, K181433, K182129
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Siemens Shenzhen Magnetic Resonance Ltd.
- NAI 2017-03-03 Siemens Shenzhen Magnetic Resonance Ltd. - MR · 0 citations
- VAI 2015-02-12 Siemens Shenzhen Magnetic Resonance Ltd. - MR · 0 citations