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CT Exprès Bottle Spike A

Model 640458 · ACIST MEDICAL SYSTEMS, INC. · DI 10841716103442

IZQ — Injector, Contrast Medium, Automatic · Class II · 21 CFR 870.1650

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.

12232019-05: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1.43/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1.4/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 2/device2024-01: 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 1.25/device2024-05: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 1.5/device2024-11: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1.25/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2/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 2/device2026-06: 0 reports for this device; peer average 1.29/device05071202030609111205070809101112020306080910111201020304050608091011120103040507080910111202030405060708091011120203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0502
2019-0701
2019-1201
2020-0201
2020-0301
2020-0601
2020-0901
2020-1101.5
2020-1202
2021-0501
2021-0702
2021-0801.5
2021-0901
2021-1001
2021-1102
2021-1201
2022-0201
2022-0301
2022-0601.43
2022-0801
2022-0901
2022-1001
2022-1101
2022-1201
2023-0101.4
2023-0201
2023-0301
2023-0401
2023-0501
2023-0601
2023-0801.5
2023-0901
2023-1001
2023-1101.5
2023-1202
2024-0101
2024-0301
2024-0401.25
2024-0501
2024-0702
2024-0801
2024-0901.5
2024-1001.5
2024-1103
2024-1201.5
2025-0201
2025-0302
2025-0401
2025-0502
2025-0601.5
2025-0701
2025-0801.5
2025-0902
2025-1001.25
2025-1101
2025-1202
2026-0201
2026-0301
2026-0401
2026-0502
2026-0601.29
This device (reports/month)Average device in IZQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K151048 — cites (transitively): K062265 (d1) — cited as predicate by K171392, K171646, K241849

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

Manufacturer compliance record — ACIST MEDICAL SYSTEMS, INC.

  • NAI 2022-02-28 Acist Medical Systems · 0 citations
  • NAI 2022-02-28 Acist Medical Systems · 0 citations
  • VAI 2019-03-04 Acist Medical Systems · 1 citations
  • VAI 2019-03-04 Acist Medical Systems · 1 citations
  • NAI 2016-03-01 Acist Medical Systems · 0 citations
  • NAI 2016-03-01 Acist Medical Systems · 0 citations
  • NAI 2012-06-06 Acist Medical Systems · 0 citations
  • NAI 2012-06-06 Acist Medical Systems · 0 citations
  • NAI 2010-03-24 Acist Medical Systems · 0 citations
  • NAI 2010-03-24 Acist Medical Systems · 0 citations