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AcuityPDR

Model Standard · RADMEDIX, LLC · DI 00810035220164

IZL — System, X-Ray, Mobile · Class II · 21 CFR 892.1720

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 (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.

23562019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 3.5/device2019-07: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1.67/device2020-06: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1.67/device2020-10: 0 reports for this device; peer average 2.5/device2020-12: 0 reports for this device; peer average 2.36/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1.29/device2021-06: 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 2/device2021-12: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1.33/device2022-05: 0 reports for this device; peer average 1.57/device2022-06: 0 reports for this device; peer average 1.38/device2022-07: 0 reports for this device; peer average 6/device2022-09: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 3.5/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1.45/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 4.5/device2023-07: 0 reports for this device; peer average 3/device2023-09: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 3/device2023-12: 0 reports for this device; peer average 2.5/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/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 1.25/device2024-08: 0 reports for this device; peer average 1/device2025-01: 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 1/device2025-07: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.33/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1.33/device2026-06: 0 reports for this device; peer average 1/device0103040709120102030406081012010203040506070809101202030405060709111201020304050607091011120304050607080103040507101101020506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0302
2019-0403.5
2019-0701
2019-0901.5
2019-1201
2020-0101.5
2020-0201
2020-0301
2020-0401.67
2020-0602
2020-0801.67
2020-1002.5
2020-1202.36
2021-0102.67
2021-0201.5
2021-0302
2021-0402
2021-0501.29
2021-0601
2021-0702
2021-0801.5
2021-0901
2021-1002
2021-1201
2022-0203
2022-0302
2022-0401.33
2022-0501.57
2022-0601.38
2022-0706
2022-0901
2022-1103.5
2022-1202
2023-0102
2023-0201.5
2023-0303
2023-0401.45
2023-0502
2023-0604.5
2023-0703
2023-0903
2023-1002
2023-1103
2023-1202.5
2024-0302
2024-0401
2024-0502
2024-0601
2024-0701.25
2024-0801
2025-0101
2025-0302
2025-0401
2025-0501
2025-0701
2025-1001
2025-1101.33
2026-0101
2026-0201
2026-0501.33
2026-0601
This device (reports/month)Average device in IZL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K200726 — cites (transitively): K130883 (d1), K141440 (d1), K150929 (d1), K152172 (d1), K162552 (d1), K162555 (d1), K171137 (d1), K191451 (d1), K192400 (d1), K193017 (d1), K131211 (d2), K140551 (d2), K122865 (d2), K110033 (d2), K150766 (d2), K151942 (d2), K142475 (d2), K040046 (d2), K052721 (d2), K141885 (d2), K143257 (d2), K153059 (d2), K171353 (d2), K091364 (d3), K120020 (d3), K083645 (d3), K122495 (d3), K100449 (d3), K091090 (d3), K090238 (d3), K091436 (d3), K103591 (d3), K111682 (d3), K130337 (d3), K130377 (d3), K131121 (d3), K133782 (d3), K140825 (d3), K130464 (d3), K162687 (d3), K082627 (d4), K024147 (d4), K090742 (d4), K042876 (d4), K063283 (d4), K080582 (d4), K093831 (d4), K090279 (d4), K101517 (d4), K131106 (d4), K133693 (d4), K143232 (d4), K161345 (d4), K043437 (d5) — cited as predicate by K201058, K202350

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

Manufacturer compliance record — RADMEDIX, LLC

  • NAI 2023-11-16 RadmediX LLC · 0 citations
  • NAI 2023-11-16 RadmediX LLC · 0 citations
  • NAI 2019-04-16 RadmediX LLC · 0 citations
  • NAI 2019-04-16 RadmediX LLC · 0 citations