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TOP LEVEL BIOGRAPH 64-4R W/O CT

Model 10245856 · SIEMENS MEDICAL SOLUTIONS USA, INC. · DI 04056869001678

KPS — System, Tomography, Computed, Emission · Class II · 21 CFR 892.1200

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 (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.

12342019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 4/device2019-08: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 3/device2024-05: 0 reports for this device; peer average 3.33/device2024-06: 0 reports for this device; peer average 3/device2024-08: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device0304050801030902040509061203040506080206101112
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0402
2019-0504
2019-0802
2020-0101
2020-0302
2020-0901
2021-0202
2022-0403
2022-0501
2022-0902
2023-0601
2023-1201
2024-0301
2024-0403
2024-0503.33
2024-0603
2024-0801.5
2025-0201
2025-0601
2025-1001
2025-1101
2025-1201
This device (reports/month)Average device in KPS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K141971 — cites (transitively): K083852 (d1), K123737 (d1), K140232 (d1), K113448 (d2), K013522 (d2), K040577 (d2), K040655 (d2), K133424 (d2)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — SIEMENS MEDICAL SOLUTIONS USA, INC.

  • VAI 2024-01-31 Siemens Medical Solutions USA, Inc. · 1 citations
  • VAI 2024-01-31 Siemens Medical Solutions USA, Inc. · 1 citations
  • VAI 2023-01-06 Siemens Medical Solutions USA, Inc. · 5 citations
  • VAI 2023-01-06 Siemens Medical Solutions USA, Inc. · 5 citations
  • VAI 2022-10-26 Siemens Medical Solutions USA, Inc · 3 citations
  • NAI 2019-09-18 Siemens Medical Solutions USA Inc · 0 citations
  • NAI 2019-06-10 Siemens Medical Solutions USA, Inc. · 0 citations
  • NAI 2019-06-10 Siemens Medical Solutions USA, Inc. · 0 citations
  • NAI 2019-06-07 Siemens Medical Solutions USA, Inc. · 0 citations
  • NAI 2019-06-07 Siemens Medical Solutions USA, Inc. · 0 citations
  • NAI 2019-06-06 Siemens Medical Solutions USA, Inc. · 0 citations
  • NAI 2017-04-27 Siemens Medical Solutions USA, Inc. · 0 citations
  • VAI 2016-04-15 Siemens Medical Solutions USA, Inc. · 2 citations
  • NAI 2015-09-09 Siemens Medical Solutions USA, Inc. · 0 citations
  • NAI 2015-09-09 Siemens Medical Solutions USA, Inc. · 0 citations
  • VAI 2015-03-27 Siemens Medical Solutions USA, Inc. · 6 citations
  • VAI 2014-12-12 Siemens Medical Solutions USA, Inc. · 1 citations
  • VAI 2014-12-12 Siemens Medical Solutions USA, Inc. · 1 citations
  • NAI 2014-11-07 Siemens Medical Solutions USA, Inc · 0 citations
  • NAI 2014-07-25 Siemens Medical Solutions USA Inc · 3 citations