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Brainlab Elements Image Fusion

Model 4.0 · Brainlab SE · DI 04056481140816

JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750

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

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 (4)

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.

Injury: 4

3610132019-01: 0 reports for this device; peer average 5.05/device2019-02: 0 reports for this device; peer average 6.94/device2019-03: 0 reports for this device; peer average 5.26/device2019-04: 0 reports for this device; peer average 6.35/device2019-05: 0 reports for this device; peer average 7.39/device2019-06: 0 reports for this device; peer average 6.44/device2019-07: 0 reports for this device; peer average 5.53/device2019-08: 0 reports for this device; peer average 12.69/device2019-09: 0 reports for this device; peer average 6.07/device2019-10: 0 reports for this device; peer average 4.24/device2019-11: 0 reports for this device; peer average 5.38/device2019-12: 0 reports for this device; peer average 7.71/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 6.23/device2020-03: 0 reports for this device; peer average 7.53/device2020-04: 0 reports for this device; peer average 11.73/device2020-05: 0 reports for this device; peer average 3.75/device2020-06: 1 reports for this device; peer average 2.53/device2020-07: 0 reports for this device; peer average 2.7/device2020-08: 0 reports for this device; peer average 2.41/device2020-09: 0 reports for this device; peer average 1.94/device2020-10: 0 reports for this device; peer average 2.39/device2020-11: 0 reports for this device; peer average 2.29/device2020-12: 0 reports for this device; peer average 2.8/device2021-01: 0 reports for this device; peer average 2.04/device2021-02: 0 reports for this device; peer average 2.19/device2021-03: 0 reports for this device; peer average 2.82/device2021-04: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 3.84/device2021-06: 0 reports for this device; peer average 4/device2021-07: 0 reports for this device; peer average 3.74/device2021-08: 0 reports for this device; peer average 3.15/device2021-09: 0 reports for this device; peer average 2.35/device2021-10: 0 reports for this device; peer average 2.52/device2021-11: 0 reports for this device; peer average 2.91/device2021-12: 0 reports for this device; peer average 3.33/device2022-01: 0 reports for this device; peer average 2.28/device2022-02: 0 reports for this device; peer average 2.62/device2022-03: 0 reports for this device; peer average 2.88/device2022-04: 0 reports for this device; peer average 2.31/device2022-05: 0 reports for this device; peer average 1.83/device2022-06: 0 reports for this device; peer average 2.53/device2022-07: 0 reports for this device; peer average 3.26/device2022-08: 1 reports for this device; peer average 2.13/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 2.65/device2022-11: 0 reports for this device; peer average 2.12/device2022-12: 0 reports for this device; peer average 1.88/device2023-01: 0 reports for this device; peer average 2.29/device2023-02: 0 reports for this device; peer average 2.09/device2023-03: 0 reports for this device; peer average 2.55/device2023-04: 1 reports for this device; peer average 2.23/device2023-05: 0 reports for this device; peer average 2.15/device2023-06: 0 reports for this device; peer average 5.47/device2023-07: 0 reports for this device; peer average 2.39/device2023-08: 0 reports for this device; peer average 3.13/device2023-09: 0 reports for this device; peer average 2.51/device2023-10: 0 reports for this device; peer average 4.97/device2023-11: 0 reports for this device; peer average 2.41/device2023-12: 0 reports for this device; peer average 2.4/device2024-01: 0 reports for this device; peer average 2/device2024-02: 1 reports for this device; peer average 2.33/device2024-03: 0 reports for this device; peer average 2.33/device2024-04: 0 reports for this device; peer average 3.23/device2024-05: 0 reports for this device; peer average 2.37/device2024-06: 0 reports for this device; peer average 2.75/device2024-07: 0 reports for this device; peer average 2.51/device2024-08: 0 reports for this device; peer average 2.68/device2024-09: 0 reports for this device; peer average 2.55/device2024-10: 0 reports for this device; peer average 2.65/device2024-11: 0 reports for this device; peer average 2.32/device2024-12: 0 reports for this device; peer average 2.03/device2025-01: 0 reports for this device; peer average 4.62/device2025-02: 0 reports for this device; peer average 4.55/device2025-03: 0 reports for this device; peer average 2.09/device2025-04: 0 reports for this device; peer average 2.24/device2025-05: 0 reports for this device; peer average 2.49/device2025-06: 0 reports for this device; peer average 2.46/device2025-07: 0 reports for this device; peer average 2.51/device2025-08: 0 reports for this device; peer average 2.87/device2025-09: 0 reports for this device; peer average 2.49/device2025-10: 0 reports for this device; peer average 7.33/device2025-11: 0 reports for this device; peer average 2.37/device2025-12: 0 reports for this device; peer average 5.18/device2026-01: 0 reports for this device; peer average 5.92/device2026-02: 0 reports for this device; peer average 3.24/device2026-03: 0 reports for this device; peer average 12.28/device2026-04: 0 reports for this device; peer average 8.33/device2026-05: 0 reports for this device; peer average 12.16/device2026-06: 0 reports for this device; peer average 5.26/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105.05
2019-0206.94
2019-0305.26
2019-0406.35
2019-0507.39
2019-0606.44
2019-0705.53
2019-08012.69
2019-0906.07
2019-1004.24
2019-1105.38
2019-1207.71
2020-0103
2020-0206.23
2020-0307.53
2020-04011.73
2020-0503.75
2020-0612.53
2020-0702.7
2020-0802.41
2020-0901.94
2020-1002.39
2020-1102.29
2020-1202.8
2021-0102.04
2021-0202.19
2021-0302.82
2021-0403
2021-0503.84
2021-0604
2021-0703.74
2021-0803.15
2021-0902.35
2021-1002.52
2021-1102.91
2021-1203.33
2022-0102.28
2022-0202.62
2022-0302.88
2022-0402.31
2022-0501.83
2022-0602.53
2022-0703.26
2022-0812.13
2022-0902.82
2022-1002.65
2022-1102.12
2022-1201.88
2023-0102.29
2023-0202.09
2023-0302.55
2023-0412.23
2023-0502.15
2023-0605.47
2023-0702.39
2023-0803.13
2023-0902.51
2023-1004.97
2023-1102.41
2023-1202.4
2024-0102
2024-0212.33
2024-0302.33
2024-0403.23
2024-0502.37
2024-0602.75
2024-0702.51
2024-0802.68
2024-0902.55
2024-1002.65
2024-1102.32
2024-1202.03
2025-0104.62
2025-0204.55
2025-0302.09
2025-0402.24
2025-0502.49
2025-0602.46
2025-0702.51
2025-0802.87
2025-0902.49
2025-1007.33
2025-1102.37
2025-1205.18
2026-0105.92
2026-0203.24
2026-03012.28
2026-0408.33
2026-05012.16
2026-0605.26
This device (reports/month)Average device in JAK, LLZ (reports/device/month)

Regulatory clearances

  • K212420 SESE 2021-12-16 (k number procode)
  • K170816 SESE 2017-09-26 (k number procode)

Predicate lineage

K170816 — cites (transitively): K101228 (d1), K113732 (d1), K071964 (d2), K052424 (d2) — cited as predicate by K190042, K212420

K212420 — cites (transitively): K113732 (d1), K170816 (d1), K183105 (d1), K190042 (d1), K052424 (d2), K101228 (d2), K073468 (d2), K173619 (d2), K080886 (d2), K071964 (d3), K161841 (d3) — cited as predicate by K223106, K260576

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

Manufacturer compliance record — Brainlab SE

  • NAI 2025-02-20 Brainlab SE · 0 citations
  • NAI 2025-02-20 Brainlab SE · 0 citations
  • NAI 2016-02-25 Brainlab SE · 0 citations
  • NAI 2016-02-25 Brainlab SE · 0 citations
  • VAI 2013-06-21 Brainlab SE · 3 citations
  • VAI 2013-06-21 Brainlab SE · 3 citations
  • NAI 2011-05-27 Brainlab SE · 0 citations
  • NAI 2011-05-27 Brainlab SE · 0 citations