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Model 11546418 · Siemens Healthcare GmbH · DI 04056869287393

MUJ — System, Planning, Radiation Therapy Treatment · Class II · 21 CFR 892.5050

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 (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.

12352019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.14/device2019-06: 0 reports for this device; peer average 2.29/device2019-07: 0 reports for this device; peer average 1.14/device2019-08: 0 reports for this device; peer average 1.57/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.14/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.14/device2020-03: 0 reports for this device; peer average 4.57/device2020-04: 0 reports for this device; peer average 2.29/device2020-05: 0 reports for this device; peer average 1.14/device2020-07: 0 reports for this device; peer average 2.13/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.14/device2020-11: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2.29/device2021-08: 0 reports for this device; peer average 2.29/device2021-10: 0 reports for this device; peer average 1.71/device2021-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1.33/device2022-12: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 1.14/device2023-03: 0 reports for this device; peer average 2.5/device2023-04: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.2/device2023-12: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device040506070809101112020304050708091107081012010203060809111201030409101203051002040608091011120406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-0501.14
2019-0602.29
2019-0701.14
2019-0801.57
2019-0901
2019-1001
2019-1101.14
2019-1201
2020-0201.14
2020-0304.57
2020-0402.29
2020-0501.14
2020-0702.13
2020-0801
2020-0901.14
2020-1102
2021-0702.29
2021-0802.29
2021-1001.71
2021-1201.5
2022-0101
2022-0201
2022-0301
2022-0602
2022-0801
2022-0901
2022-1101.33
2022-1201.5
2023-0101.14
2023-0302.5
2023-0401.67
2023-0901
2023-1001.2
2023-1201
2024-0301
2024-0501
2024-1001.5
2025-0201
2025-0401
2025-0601
2025-0801
2025-0901
2025-1002
2025-1101
2025-1201
2026-0401
2026-0601
This device (reports/month)Average device in MUJ (reports/device/month)

Regulatory clearances

  • K220783 SESE 2022-09-07 (k number procode)

Predicate lineage

K220783 — cites (transitively): K123584 (d1), K211379 (d1), K072728 (d2), K112020 (d2), K120579 (d2), K201444 (d2), K043469 (d3), K061214 (d3), K083524 (d3), K092519 (d3), K192065 (d3), K173635 (d4), K151887 (d5), K162370 (d5), K163234 (d5), K163289 (d5), K101119 (d6), K151380 (d6), K121434 (d6), K133226 (d6), K153343 (d6), K150757 (d6), K153220 (d6), K061006 (d7), K061097 (d7), K071310 (d7), K080799 (d7), K082427 (d7), K091114 (d7), K103274 (d7), K103429 (d7), K123737 (d7), K123938 (d7), K133648 (d7), K837107 (d7), K093621 (d7), K150843 (d7), K152036 (d7), K133435 (d7), K141977 (d7), K151579 (d7), K151597 (d7), K073003 (d8), K091373 (d8), K053042 (d8), K081453 (d8), K113448 (d8), K063524 (d8), K073194 (d8), K090038 (d8), K121160 (d8), K121459 (d8), K123510 (d8), K132831 (d8), K132951 (d8), K140253 (d8), K140998 (d8), K130885 (d8), K132119 (d8), K050263 (d8), K143311 (d8), K143400 (d8), K143401 (d8) — cited as predicate by K232000, K232799, K232856, K232899, K252304

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