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syngo.mMR General

Model 11234877 · Siemens Healthcare GmbH · DI 04056869012872

LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050

LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000

UDILibrary device dossier · generated 2026-09-11 · 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.

61219252019-01: 0 reports for this device; peer average 5/device2019-02: 0 reports for this device; peer average 10.33/device2019-03: 0 reports for this device; peer average 7.33/device2019-04: 0 reports for this device; peer average 5.24/device2019-05: 0 reports for this device; peer average 10.78/device2019-06: 0 reports for this device; peer average 9/device2019-07: 0 reports for this device; peer average 8.63/device2019-08: 0 reports for this device; peer average 24.67/device2019-09: 0 reports for this device; peer average 9.5/device2019-10: 0 reports for this device; peer average 5.2/device2019-11: 0 reports for this device; peer average 6.67/device2019-12: 0 reports for this device; peer average 11.86/device2020-01: 0 reports for this device; peer average 4.38/device2020-02: 0 reports for this device; peer average 9.55/device2020-03: 0 reports for this device; peer average 9.08/device2020-04: 0 reports for this device; peer average 14.75/device2020-05: 0 reports for this device; peer average 6/device2020-06: 0 reports for this device; peer average 2.6/device2020-07: 0 reports for this device; peer average 2.93/device2020-08: 0 reports for this device; peer average 3.43/device2020-09: 0 reports for this device; peer average 1.81/device2020-10: 0 reports for this device; peer average 2.67/device2020-11: 0 reports for this device; peer average 2.36/device2020-12: 0 reports for this device; peer average 2.69/device2021-01: 0 reports for this device; peer average 2.5/device2021-02: 0 reports for this device; peer average 2.82/device2021-03: 0 reports for this device; peer average 3.31/device2021-04: 0 reports for this device; peer average 3.5/device2021-05: 0 reports for this device; peer average 3.5/device2021-06: 0 reports for this device; peer average 3.08/device2021-07: 0 reports for this device; peer average 4.31/device2021-08: 0 reports for this device; peer average 3.8/device2021-09: 0 reports for this device; peer average 2.18/device2021-10: 0 reports for this device; peer average 3.13/device2021-11: 0 reports for this device; peer average 3.08/device2021-12: 0 reports for this device; peer average 4.18/device2022-01: 0 reports for this device; peer average 2.6/device2022-02: 0 reports for this device; peer average 2.58/device2022-03: 0 reports for this device; peer average 2.65/device2022-04: 0 reports for this device; peer average 1.79/device2022-05: 0 reports for this device; peer average 1.7/device2022-06: 0 reports for this device; peer average 3.43/device2022-07: 0 reports for this device; peer average 2.47/device2022-08: 0 reports for this device; peer average 2.55/device2022-09: 0 reports for this device; peer average 2.25/device2022-10: 0 reports for this device; peer average 2.47/device2022-11: 0 reports for this device; peer average 1.81/device2022-12: 0 reports for this device; peer average 1.91/device2023-01: 0 reports for this device; peer average 1.93/device2023-02: 0 reports for this device; peer average 2.2/device2023-03: 0 reports for this device; peer average 2.64/device2023-04: 0 reports for this device; peer average 2.14/device2023-05: 0 reports for this device; peer average 1.69/device2023-06: 0 reports for this device; peer average 2.42/device2023-07: 0 reports for this device; peer average 2.29/device2023-08: 0 reports for this device; peer average 2.13/device2023-09: 0 reports for this device; peer average 2.05/device2023-10: 0 reports for this device; peer average 2.84/device2023-11: 0 reports for this device; peer average 2.18/device2023-12: 0 reports for this device; peer average 1.78/device2024-01: 0 reports for this device; peer average 1.84/device2024-02: 0 reports for this device; peer average 2.58/device2024-03: 0 reports for this device; peer average 2.57/device2024-04: 0 reports for this device; peer average 4.09/device2024-05: 0 reports for this device; peer average 2.37/device2024-06: 0 reports for this device; peer average 2.36/device2024-07: 0 reports for this device; peer average 2.82/device2024-08: 0 reports for this device; peer average 2.93/device2024-09: 0 reports for this device; peer average 2.85/device2024-10: 0 reports for this device; peer average 2.75/device2024-11: 0 reports for this device; peer average 2.38/device2024-12: 0 reports for this device; peer average 1.73/device2025-01: 0 reports for this device; peer average 5.76/device2025-02: 0 reports for this device; peer average 5.09/device2025-03: 0 reports for this device; peer average 2.48/device2025-04: 0 reports for this device; peer average 2.4/device2025-05: 0 reports for this device; peer average 2.43/device2025-06: 0 reports for this device; peer average 3.82/device2025-07: 0 reports for this device; peer average 4.33/device2025-08: 0 reports for this device; peer average 5.95/device2025-09: 0 reports for this device; peer average 3.76/device2025-10: 0 reports for this device; peer average 7.17/device2025-11: 0 reports for this device; peer average 3.61/device2025-12: 0 reports for this device; peer average 6.8/device2026-01: 0 reports for this device; peer average 6.63/device2026-02: 0 reports for this device; peer average 4.07/device2026-03: 0 reports for this device; peer average 10.41/device2026-04: 0 reports for this device; peer average 8.26/device2026-05: 0 reports for this device; peer average 12.87/device2026-06: 0 reports for this device; peer average 6.16/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105
2019-02010.33
2019-0307.33
2019-0405.24
2019-05010.78
2019-0609
2019-0708.63
2019-08024.67
2019-0909.5
2019-1005.2
2019-1106.67
2019-12011.86
2020-0104.38
2020-0209.55
2020-0309.08
2020-04014.75
2020-0506
2020-0602.6
2020-0702.93
2020-0803.43
2020-0901.81
2020-1002.67
2020-1102.36
2020-1202.69
2021-0102.5
2021-0202.82
2021-0303.31
2021-0403.5
2021-0503.5
2021-0603.08
2021-0704.31
2021-0803.8
2021-0902.18
2021-1003.13
2021-1103.08
2021-1204.18
2022-0102.6
2022-0202.58
2022-0302.65
2022-0401.79
2022-0501.7
2022-0603.43
2022-0702.47
2022-0802.55
2022-0902.25
2022-1002.47
2022-1101.81
2022-1201.91
2023-0101.93
2023-0202.2
2023-0302.64
2023-0402.14
2023-0501.69
2023-0602.42
2023-0702.29
2023-0802.13
2023-0902.05
2023-1002.84
2023-1102.18
2023-1201.78
2024-0101.84
2024-0202.58
2024-0302.57
2024-0404.09
2024-0502.37
2024-0602.36
2024-0702.82
2024-0802.93
2024-0902.85
2024-1002.75
2024-1102.38
2024-1201.73
2025-0105.76
2025-0205.09
2025-0302.48
2025-0402.4
2025-0502.43
2025-0603.82
2025-0704.33
2025-0805.95
2025-0903.76
2025-1007.17
2025-1103.61
2025-1206.8
2026-0106.63
2026-0204.07
2026-03010.41
2026-0408.26
2026-05012.87
2026-0606.16
This device (reports/month)Average device in LLZ, LNH (reports/device/month)

Regulatory clearances

  • K140897 SESE 2014-07-18 (k number procode)

Predicate lineage

K133401 — cites (transitively): K130749 (d1), K121434 (d2), K123375 (d2), K082427 (d3), K091114 (d3), K103274 (d3), K053042 (d4) — cited as predicate by K140897, K151353, K172999, K180336, K183164

K140897 — cites (transitively): K133401 (d1), K130749 (d2), K121434 (d3), K123375 (d3), K082427 (d4), K091114 (d4), K103274 (d4), K053042 (d5)

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