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Model 302582-9205-000 · Carl Zeiss Meditec AG · DI 04049539104359

IZI — System, X-Ray, Angiographic · Class II · 21 CFR 892.1600

UDILibrary device dossier · generated 2026-09-12 · 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.

1032073104132019-01: 0 reports for this device; peer average 4.6/device2019-02: 0 reports for this device; peer average 3.88/device2019-03: 0 reports for this device; peer average 4.83/device2019-04: 0 reports for this device; peer average 9.73/device2019-05: 0 reports for this device; peer average 4.75/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 2.33/device2019-09: 0 reports for this device; peer average 3.33/device2019-10: 0 reports for this device; peer average 2.83/device2019-11: 0 reports for this device; peer average 1.67/device2019-12: 0 reports for this device; peer average 3.11/device2020-01: 0 reports for this device; peer average 2.5/device2020-02: 0 reports for this device; peer average 3.43/device2020-03: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.8/device2020-07: 0 reports for this device; peer average 2.11/device2020-08: 0 reports for this device; peer average 1.67/device2020-09: 0 reports for this device; peer average 2.75/device2020-10: 0 reports for this device; peer average 2.38/device2020-11: 0 reports for this device; peer average 2.69/device2020-12: 0 reports for this device; peer average 2.2/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 4.91/device2021-05: 0 reports for this device; peer average 4.83/device2021-06: 0 reports for this device; peer average 5.93/device2021-07: 0 reports for this device; peer average 3.7/device2021-08: 0 reports for this device; peer average 3.85/device2021-09: 0 reports for this device; peer average 4.6/device2021-10: 0 reports for this device; peer average 2.42/device2021-11: 0 reports for this device; peer average 3.46/device2021-12: 0 reports for this device; peer average 4.23/device2022-01: 0 reports for this device; peer average 2.18/device2022-02: 0 reports for this device; peer average 2.54/device2022-03: 0 reports for this device; peer average 3.77/device2022-04: 0 reports for this device; peer average 4.1/device2022-05: 0 reports for this device; peer average 4.2/device2022-06: 0 reports for this device; peer average 5.71/device2022-07: 0 reports for this device; peer average 3.6/device2022-08: 0 reports for this device; peer average 3.7/device2022-09: 0 reports for this device; peer average 4.4/device2022-10: 0 reports for this device; peer average 25.92/device2022-11: 0 reports for this device; peer average 83.33/device2022-12: 0 reports for this device; peer average 97.38/device2023-01: 0 reports for this device; peer average 136.33/device2023-02: 0 reports for this device; peer average 115.2/device2023-03: 0 reports for this device; peer average 187/device2023-04: 0 reports for this device; peer average 110.83/device2023-05: 0 reports for this device; peer average 59.59/device2023-06: 0 reports for this device; peer average 62.55/device2023-07: 0 reports for this device; peer average 36.86/device2023-08: 0 reports for this device; peer average 49.46/device2023-09: 0 reports for this device; peer average 60/device2023-10: 0 reports for this device; peer average 77.11/device2023-11: 0 reports for this device; peer average 80.18/device2023-12: 0 reports for this device; peer average 87/device2024-01: 0 reports for this device; peer average 73.4/device2024-02: 0 reports for this device; peer average 109.3/device2024-03: 0 reports for this device; peer average 76.7/device2024-04: 0 reports for this device; peer average 55.73/device2024-05: 0 reports for this device; peer average 54.36/device2024-06: 0 reports for this device; peer average 82.14/device2024-07: 0 reports for this device; peer average 85.13/device2024-08: 0 reports for this device; peer average 77.33/device2024-09: 0 reports for this device; peer average 72.3/device2024-10: 0 reports for this device; peer average 75.4/device2024-11: 0 reports for this device; peer average 60.6/device2024-12: 0 reports for this device; peer average 59.33/device2025-01: 0 reports for this device; peer average 59.7/device2025-02: 0 reports for this device; peer average 93.2/device2025-03: 0 reports for this device; peer average 58.3/device2025-04: 0 reports for this device; peer average 130.86/device2025-05: 0 reports for this device; peer average 123.14/device2025-06: 0 reports for this device; peer average 122.89/device2025-07: 0 reports for this device; peer average 128.22/device2025-08: 0 reports for this device; peer average 179.27/device2025-09: 0 reports for this device; peer average 339/device2025-10: 0 reports for this device; peer average 413.29/device2025-11: 0 reports for this device; peer average 215.6/device2025-12: 0 reports for this device; peer average 38.18/device2026-01: 0 reports for this device; peer average 44.11/device2026-02: 0 reports for this device; peer average 26.67/device2026-03: 0 reports for this device; peer average 37/device2026-04: 0 reports for this device; peer average 18.88/device2026-05: 0 reports for this device; peer average 27.36/device2026-06: 0 reports for this device; peer average 23.47/device01020304050607080910111201020306070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.6
2019-0203.88
2019-0304.83
2019-0409.73
2019-0504.75
2019-0603
2019-0703.5
2019-0802.33
2019-0903.33
2019-1002.83
2019-1101.67
2019-1203.11
2020-0102.5
2020-0203.43
2020-0301
2020-0602.8
2020-0702.11
2020-0801.67
2020-0902.75
2020-1002.38
2020-1102.69
2020-1202.2
2021-0102
2021-0202
2021-0303
2021-0404.91
2021-0504.83
2021-0605.93
2021-0703.7
2021-0803.85
2021-0904.6
2021-1002.42
2021-1103.46
2021-1204.23
2022-0102.18
2022-0202.54
2022-0303.77
2022-0404.1
2022-0504.2
2022-0605.71
2022-0703.6
2022-0803.7
2022-0904.4
2022-10025.92
2022-11083.33
2022-12097.38
2023-010136.33
2023-020115.2
2023-030187
2023-040110.83
2023-05059.59
2023-06062.55
2023-07036.86
2023-08049.46
2023-09060
2023-10077.11
2023-11080.18
2023-12087
2024-01073.4
2024-020109.3
2024-03076.7
2024-04055.73
2024-05054.36
2024-06082.14
2024-07085.13
2024-08077.33
2024-09072.3
2024-10075.4
2024-11060.6
2024-12059.33
2025-01059.7
2025-02093.2
2025-03058.3
2025-040130.86
2025-050123.14
2025-060122.89
2025-070128.22
2025-080179.27
2025-090339
2025-100413.29
2025-110215.6
2025-12038.18
2026-01044.11
2026-02026.67
2026-03037
2026-04018.88
2026-05027.36
2026-06023.47
This device (reports/month)Average device in IZI (reports/device/month)

Regulatory clearances

  • K162991 SESD 2017-07-24 (k number procode)

Predicate lineage

K162991 — cited as predicate by K181116, K231075

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

Manufacturer compliance record — Carl Zeiss Meditec AG

  • NAI 2024-03-26 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2018-10-25 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2017-02-24 Carl Zeiss Meditec AG · 0 citations
  • NAI 2016-03-25 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2014-09-18 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2014-08-15 Carl Zeiss Meditec AG · 0 citations
  • NAI 2014-03-26 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2011-11-17 Carl Zeiss Meditec Inc. · 0 citations
  • NAI 2011-06-22 Carl Zeiss Meditec Inc. · 0 citations