Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

ExacTrac Dynamic

Model 2.0 · Brainlab SE · DI 04056481144609

IYE — Accelerator, Linear, Medical · 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 (1)

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: 1

358102019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.67/device2019-04: 0 reports for this device; peer average 2.33/device2019-05: 0 reports for this device; peer average 1.25/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1.2/device2019-09: 0 reports for this device; peer average 4/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1.33/device2020-01: 0 reports for this device; peer average 3.6/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 1.83/device2020-04: 0 reports for this device; peer average 2.67/device2020-05: 0 reports for this device; peer average 4.2/device2020-06: 0 reports for this device; peer average 2.6/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 3.4/device2020-10: 0 reports for this device; peer average 4.75/device2020-11: 0 reports for this device; peer average 2.4/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 1.33/device2021-02: 0 reports for this device; peer average 1.67/device2021-03: 0 reports for this device; peer average 1.8/device2021-04: 0 reports for this device; peer average 1.8/device2021-05: 0 reports for this device; peer average 1.33/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 3.4/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.17/device2021-11: 0 reports for this device; peer average 2.5/device2021-12: 0 reports for this device; peer average 4.25/device2022-01: 0 reports for this device; peer average 1.6/device2022-02: 0 reports for this device; peer average 1.4/device2022-03: 0 reports for this device; peer average 3.4/device2022-04: 0 reports for this device; peer average 1.33/device2022-06: 0 reports for this device; peer average 2.77/device2022-07: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 2.17/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 1.33/device2022-11: 0 reports for this device; peer average 2.82/device2022-12: 0 reports for this device; peer average 1.17/device2023-01: 0 reports for this device; peer average 4.57/device2023-02: 0 reports for this device; peer average 2.14/device2023-03: 0 reports for this device; peer average 3.57/device2023-04: 0 reports for this device; peer average 10.1/device2023-05: 0 reports for this device; peer average 6.29/device2023-06: 0 reports for this device; peer average 4.4/device2023-07: 0 reports for this device; peer average 3.22/device2023-08: 0 reports for this device; peer average 1.75/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.33/device2023-11: 0 reports for this device; peer average 2.33/device2023-12: 0 reports for this device; peer average 1.8/device2024-01: 0 reports for this device; peer average 1.17/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.33/device2024-04: 0 reports for this device; peer average 1.75/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1.25/device2024-10: 0 reports for this device; peer average 1.67/device2024-11: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.6/device2025-02: 0 reports for this device; peer average 1.33/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2.67/device2025-06: 0 reports for this device; peer average 5.67/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 1.25/device2025-09: 0 reports for this device; peer average 1.67/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/device2026-01: 1 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device0203040507080910111201020304050607081011120102030405060708091011120102030406070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0302.67
2019-0402.33
2019-0501.25
2019-0701
2019-0801.2
2019-0904
2019-1003
2019-1101.33
2019-1201.33
2020-0103.6
2020-0201.33
2020-0301.83
2020-0402.67
2020-0504.2
2020-0602.6
2020-0701
2020-0803.4
2020-1004.75
2020-1102.4
2020-1203
2021-0101.33
2021-0201.67
2021-0301.8
2021-0401.8
2021-0501.33
2021-0602
2021-0703.4
2021-0802
2021-0902
2021-1001.17
2021-1102.5
2021-1204.25
2022-0101.6
2022-0201.4
2022-0303.4
2022-0401.33
2022-0602.77
2022-0703
2022-0802.17
2022-0902.17
2022-1001.33
2022-1102.82
2022-1201.17
2023-0104.57
2023-0202.14
2023-0303.57
2023-04010.1
2023-0506.29
2023-0604.4
2023-0703.22
2023-0801.75
2023-0902
2023-1001.33
2023-1102.33
2023-1201.8
2024-0101.17
2024-0201
2024-0301.33
2024-0401.75
2024-0502
2024-0601
2024-0701.6
2024-0801
2024-0901.25
2024-1001.67
2024-1103
2024-1201
2025-0101.6
2025-0201.33
2025-0301.5
2025-0402
2025-0502.67
2025-0605.67
2025-0701.5
2025-0801.25
2025-0901.67
2025-1001
2025-1101
2025-1201
2026-0111.5
2026-0201
2026-0301
2026-0401
2026-0501
2026-0601
This device (reports/month)Average device in IYE (reports/device/month)

Regulatory clearances

  • K254010 SESE 2026-01-14 (k number procode)
  • K240431 SESE 2024-07-24 (k number procode)

Predicate lineage

K240431 — cites (transitively): K220338 (d1), K201276 (d2), K120789 (d3), K042720 (d4), K072506 (d4) — cited as predicate by K254010

K254010 — cites (transitively): K240431 (d1), K220338 (d2), K201276 (d3), K120789 (d4), K042720 (d5), K072506 (d5)

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