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AcuitySDR

Model Standard · RADMEDIX, LLC · DI 00810035220034

KPR — System, X-Ray, Stationary · Class II · 21 CFR 892.1680

UDILibrary device dossier · generated 2026-09-14 · 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.

24682019-02: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 1.67/device2019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 3/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 3.5/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2.67/device2023-04: 0 reports for this device; peer average 4.5/device2023-05: 0 reports for this device; peer average 1.8/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3.4/device2023-08: 0 reports for this device; peer average 3/device2023-09: 0 reports for this device; peer average 2.5/device2023-10: 0 reports for this device; peer average 2.75/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 3/device2024-01: 0 reports for this device; peer average 2.67/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2.4/device2024-04: 0 reports for this device; peer average 8.33/device2024-05: 0 reports for this device; peer average 3/device2024-06: 0 reports for this device; peer average 1.2/device2024-07: 0 reports for this device; peer average 3.33/device2024-08: 0 reports for this device; peer average 3.67/device2024-09: 0 reports for this device; peer average 3.5/device2024-10: 0 reports for this device; peer average 4.5/device2024-11: 0 reports for this device; peer average 6/device2024-12: 0 reports for this device; peer average 2.33/device2025-01: 0 reports for this device; peer average 8/device2025-02: 0 reports for this device; peer average 4.75/device2025-03: 0 reports for this device; peer average 3.25/device2025-04: 0 reports for this device; peer average 3.33/device2025-05: 0 reports for this device; peer average 3.75/device2025-06: 0 reports for this device; peer average 2.67/device2025-07: 0 reports for this device; peer average 3.6/device2025-08: 0 reports for this device; peer average 2.67/device2025-09: 0 reports for this device; peer average 1.6/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 4.4/device2025-12: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.67/device2026-03: 0 reports for this device; peer average 2.5/device2026-04: 0 reports for this device; peer average 1.5/device2026-05: 0 reports for this device; peer average 1.67/device2026-06: 0 reports for this device; peer average 2/device020405070809100708090203040608091011120102040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201.5
2019-0401.67
2019-0501
2019-0703
2019-0801.5
2019-0901
2019-1001.5
2020-0703.5
2020-0801
2020-0901.5
2021-0203
2021-0301
2021-0401
2021-0602
2021-0801
2021-0901
2021-1003
2021-1102
2021-1201.5
2022-0102
2022-0201
2022-0402
2022-0503
2022-0602
2022-0702
2022-0803
2022-0901
2022-1002
2022-1102
2022-1201.5
2023-0102.5
2023-0202
2023-0302.67
2023-0404.5
2023-0501.8
2023-0603
2023-0703.4
2023-0803
2023-0902.5
2023-1002.75
2023-1102
2023-1203
2024-0102.67
2024-0202
2024-0302.4
2024-0408.33
2024-0503
2024-0601.2
2024-0703.33
2024-0803.67
2024-0903.5
2024-1004.5
2024-1106
2024-1202.33
2025-0108
2025-0204.75
2025-0303.25
2025-0403.33
2025-0503.75
2025-0602.67
2025-0703.6
2025-0802.67
2025-0901.6
2025-1002
2025-1104.4
2025-1203
2026-0102
2026-0201.67
2026-0302.5
2026-0401.5
2026-0501.67
2026-0602
This device (reports/month)Average device in KPR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K193360 — cites (transitively): K141440 (d1), K142475 (d1), K150725 (d1), K151942 (d1), K152172 (d1), K160620 (d1), K161730 (d1), K162552 (d1), K162555 (d1), K171137 (d1), K180332 (d1), K182348 (d1), K182550 (d1), K182551 (d1), K183286 (d1), K183422 (d1), K183713 (d1), K131211 (d2), K140551 (d2), K091090 (d2), K091364 (d2), K110033 (d2), K024147 (d2), K080064 (d2), K091747 (d2), K102284 (d2), K102474 (d2), K111344 (d2), K111583 (d2), K111655 (d2), K120020 (d2), K121513 (d2), K122173 (d2), K122182 (d2), K122865 (d2), K122866 (d2), K122919 (d2), K122928 (d2), K123345 (d2), K123644 (d2), K130318 (d2), K130883 (d2), K130935 (d2), K130936 (d2), K131114 (d2), K131483 (d2), K132842 (d2), K140646 (d2), K141271 (d2), K141488 (d2), K150929 (d2), K151465 (d2), K153058 (d2), K153492 (d2), K150766 (d2), K150165 (d2), K090742 (d3), K102321 (d3), K101590 (d3), K063337 (d3), K103416 (d3), K102349 (d3), K083645 (d3), K090625 (d3), K931071 (d3), K982795 (d3), K122495 (d3), K113248 (d3), K120477 (d3), K050987 (d3), K140334 (d3), K130464 (d3), K042876 (d4), K063283 (d4), K123098 (d4) — cited as predicate by K231995

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