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Calibration Phantom Ict

Model 19148-01A · Brainlab SE · DI 04056481004569

HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-13 · 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.

5914192019-01: 0 reports for this device; peer average 9.11/device2019-02: 0 reports for this device; peer average 9.71/device2019-03: 0 reports for this device; peer average 9.79/device2019-04: 0 reports for this device; peer average 11.87/device2019-05: 0 reports for this device; peer average 13.04/device2019-06: 0 reports for this device; peer average 13.02/device2019-07: 0 reports for this device; peer average 9.88/device2019-08: 0 reports for this device; peer average 7.49/device2019-09: 0 reports for this device; peer average 7.85/device2019-10: 0 reports for this device; peer average 7.27/device2019-11: 0 reports for this device; peer average 9.91/device2019-12: 0 reports for this device; peer average 10.08/device2020-01: 0 reports for this device; peer average 8.04/device2020-02: 0 reports for this device; peer average 9.15/device2020-03: 0 reports for this device; peer average 9.62/device2020-04: 0 reports for this device; peer average 9.53/device2020-05: 0 reports for this device; peer average 11.43/device2020-06: 0 reports for this device; peer average 8.71/device2020-07: 0 reports for this device; peer average 9.7/device2020-08: 0 reports for this device; peer average 8.58/device2020-09: 0 reports for this device; peer average 8.91/device2020-10: 0 reports for this device; peer average 9.9/device2020-11: 0 reports for this device; peer average 10.94/device2020-12: 0 reports for this device; peer average 9.27/device2021-01: 0 reports for this device; peer average 9.05/device2021-02: 0 reports for this device; peer average 9.77/device2021-03: 0 reports for this device; peer average 9.35/device2021-04: 0 reports for this device; peer average 8.9/device2021-05: 0 reports for this device; peer average 9.8/device2021-06: 0 reports for this device; peer average 11.37/device2021-07: 0 reports for this device; peer average 8.74/device2021-08: 0 reports for this device; peer average 10.53/device2021-09: 0 reports for this device; peer average 13/device2021-10: 0 reports for this device; peer average 8.34/device2021-11: 0 reports for this device; peer average 11.01/device2021-12: 0 reports for this device; peer average 7.44/device2022-01: 0 reports for this device; peer average 6.82/device2022-02: 0 reports for this device; peer average 7.95/device2022-03: 0 reports for this device; peer average 9.35/device2022-04: 0 reports for this device; peer average 6.39/device2022-05: 0 reports for this device; peer average 8.87/device2022-06: 0 reports for this device; peer average 9.36/device2022-07: 0 reports for this device; peer average 8.79/device2022-08: 0 reports for this device; peer average 8.72/device2022-09: 0 reports for this device; peer average 8.74/device2022-10: 0 reports for this device; peer average 11.56/device2022-11: 0 reports for this device; peer average 10.32/device2022-12: 0 reports for this device; peer average 10.44/device2023-01: 0 reports for this device; peer average 9.14/device2023-02: 0 reports for this device; peer average 8.45/device2023-03: 0 reports for this device; peer average 10.04/device2023-04: 0 reports for this device; peer average 10.25/device2023-05: 0 reports for this device; peer average 10.82/device2023-06: 0 reports for this device; peer average 12.34/device2023-07: 0 reports for this device; peer average 14.14/device2023-08: 0 reports for this device; peer average 13.16/device2023-09: 0 reports for this device; peer average 11.4/device2023-10: 0 reports for this device; peer average 10.8/device2023-11: 0 reports for this device; peer average 14.61/device2023-12: 0 reports for this device; peer average 12.27/device2024-01: 0 reports for this device; peer average 16.51/device2024-02: 0 reports for this device; peer average 12.43/device2024-03: 0 reports for this device; peer average 14.98/device2024-04: 0 reports for this device; peer average 13.44/device2024-05: 0 reports for this device; peer average 12.95/device2024-06: 0 reports for this device; peer average 12.52/device2024-07: 0 reports for this device; peer average 13.91/device2024-08: 0 reports for this device; peer average 18.98/device2024-09: 0 reports for this device; peer average 14.7/device2024-10: 0 reports for this device; peer average 18.36/device2024-11: 0 reports for this device; peer average 10.72/device2024-12: 0 reports for this device; peer average 10.63/device2025-01: 0 reports for this device; peer average 12.32/device2025-02: 0 reports for this device; peer average 13.73/device2025-03: 0 reports for this device; peer average 12.56/device2025-04: 0 reports for this device; peer average 13.77/device2025-05: 0 reports for this device; peer average 13.22/device2025-06: 0 reports for this device; peer average 16.69/device2025-07: 0 reports for this device; peer average 12.44/device2025-08: 0 reports for this device; peer average 10.63/device2025-09: 0 reports for this device; peer average 11.02/device2025-10: 0 reports for this device; peer average 10.7/device2025-11: 0 reports for this device; peer average 9.45/device2025-12: 0 reports for this device; peer average 8.85/device2026-01: 0 reports for this device; peer average 10.24/device2026-02: 0 reports for this device; peer average 8.24/device2026-03: 0 reports for this device; peer average 8.88/device2026-04: 0 reports for this device; peer average 7.34/device2026-05: 0 reports for this device; peer average 7.59/device2026-06: 0 reports for this device; peer average 5.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0109.11
2019-0209.71
2019-0309.79
2019-04011.87
2019-05013.04
2019-06013.02
2019-0709.88
2019-0807.49
2019-0907.85
2019-1007.27
2019-1109.91
2019-12010.08
2020-0108.04
2020-0209.15
2020-0309.62
2020-0409.53
2020-05011.43
2020-0608.71
2020-0709.7
2020-0808.58
2020-0908.91
2020-1009.9
2020-11010.94
2020-1209.27
2021-0109.05
2021-0209.77
2021-0309.35
2021-0408.9
2021-0509.8
2021-06011.37
2021-0708.74
2021-08010.53
2021-09013
2021-1008.34
2021-11011.01
2021-1207.44
2022-0106.82
2022-0207.95
2022-0309.35
2022-0406.39
2022-0508.87
2022-0609.36
2022-0708.79
2022-0808.72
2022-0908.74
2022-10011.56
2022-11010.32
2022-12010.44
2023-0109.14
2023-0208.45
2023-03010.04
2023-04010.25
2023-05010.82
2023-06012.34
2023-07014.14
2023-08013.16
2023-09011.4
2023-10010.8
2023-11014.61
2023-12012.27
2024-01016.51
2024-02012.43
2024-03014.98
2024-04013.44
2024-05012.95
2024-06012.52
2024-07013.91
2024-08018.98
2024-09014.7
2024-10018.36
2024-11010.72
2024-12010.63
2025-01012.32
2025-02013.73
2025-03012.56
2025-04013.77
2025-05013.22
2025-06016.69
2025-07012.44
2025-08010.63
2025-09011.02
2025-10010.7
2025-1109.45
2025-1208.85
2026-01010.24
2026-0208.24
2026-0308.88
2026-0407.34
2026-0507.59
2026-0605.85
This device (reports/month)Average device in HAW, OLO (reports/device/month)

Regulatory clearances

  • K234047 SESE 2024-03-20 (k number procode)

Predicate lineage

K092467 — cites (transitively): K082060 (d1) — cited as predicate by K171661, K192579, K192703, K193307, K201752, K231897

K183605 — cites (transitively): K083310 (d1) — cited as predicate by K193307, K201661, K202320, K203679, K212245, K220554, K242271, K252755

K192703 — cites (transitively): K070106 (d1), K092467 (d1), K082060 (d2) — cited as predicate by K213989, K223288, K223864

K234047 — cites (transitively): K203679 (d1), K183605 (d2), K083310 (d3)

K252562 — cites (transitively): K221618 (d1), K110204 (d2), K202320 (d2), K212245 (d2), K042721 (d3), K062358 (d3), K083483 (d3), K183605 (d3), K170011 (d3), K050438 (d4), K153660 (d4), K083310 (d4), K150216 (d5), K992927 (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