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KBA3D

Model V1.1.X · S.M.A.I.O · DI 03701313000479

LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050

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.

61219252019-01: 0 reports for this device; peer average 5/device2019-02: 0 reports for this device; peer average 11.5/device2019-03: 0 reports for this device; peer average 8.71/device2019-04: 0 reports for this device; peer average 7.44/device2019-05: 0 reports for this device; peer average 15.67/device2019-06: 0 reports for this device; peer average 11/device2019-07: 0 reports for this device; peer average 12.6/device2019-08: 0 reports for this device; peer average 24.67/device2019-09: 0 reports for this device; peer average 9.5/device2019-10: 0 reports for this device; peer average 9/device2019-11: 0 reports for this device; peer average 9.5/device2019-12: 0 reports for this device; peer average 13.67/device2020-01: 0 reports for this device; peer average 4.38/device2020-02: 0 reports for this device; peer average 10.4/device2020-03: 0 reports for this device; peer average 9.75/device2020-04: 0 reports for this device; peer average 14.75/device2020-05: 0 reports for this device; peer average 6/device2020-06: 0 reports for this device; peer average 2.6/device2020-07: 0 reports for this device; peer average 3.6/device2020-08: 0 reports for this device; peer average 3.38/device2020-09: 0 reports for this device; peer average 1.87/device2020-10: 0 reports for this device; peer average 3.22/device2020-11: 0 reports for this device; peer average 2.36/device2020-12: 0 reports for this device; peer average 3.4/device2021-01: 0 reports for this device; peer average 2.91/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 3.5/device2021-04: 0 reports for this device; peer average 3.5/device2021-05: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 3.08/device2021-07: 0 reports for this device; peer average 4.58/device2021-08: 0 reports for this device; peer average 4/device2021-09: 0 reports for this device; peer average 2.5/device2021-10: 0 reports for this device; peer average 3.58/device2021-11: 0 reports for this device; peer average 3.45/device2021-12: 0 reports for this device; peer average 4.5/device2022-01: 0 reports for this device; peer average 3.29/device2022-02: 0 reports for this device; peer average 2.8/device2022-03: 0 reports for this device; peer average 3.67/device2022-04: 0 reports for this device; peer average 2.15/device2022-05: 0 reports for this device; peer average 1.78/device2022-06: 0 reports for this device; peer average 4/device2022-07: 0 reports for this device; peer average 2.83/device2022-08: 0 reports for this device; peer average 2.7/device2022-09: 0 reports for this device; peer average 2.75/device2022-10: 0 reports for this device; peer average 3.33/device2022-11: 0 reports for this device; peer average 2.18/device2022-12: 0 reports for this device; peer average 2.13/device2023-01: 0 reports for this device; peer average 2.27/device2023-02: 0 reports for this device; peer average 2.42/device2023-03: 0 reports for this device; peer average 2.47/device2023-04: 0 reports for this device; peer average 2.28/device2023-05: 0 reports for this device; peer average 1.56/device2023-06: 0 reports for this device; peer average 2.85/device2023-07: 0 reports for this device; peer average 2.75/device2023-08: 0 reports for this device; peer average 2.11/device2023-09: 0 reports for this device; peer average 2.05/device2023-10: 0 reports for this device; peer average 3.58/device2023-11: 0 reports for this device; peer average 2.22/device2023-12: 0 reports for this device; peer average 1.91/device2024-01: 0 reports for this device; peer average 2.07/device2024-02: 0 reports for this device; peer average 2.76/device2024-03: 0 reports for this device; peer average 2.75/device2024-04: 0 reports for this device; peer average 4.72/device2024-05: 0 reports for this device; peer average 2.61/device2024-06: 0 reports for this device; peer average 2.58/device2024-07: 0 reports for this device; peer average 3.05/device2024-08: 0 reports for this device; peer average 3.33/device2024-09: 0 reports for this device; peer average 3.33/device2024-10: 0 reports for this device; peer average 3.42/device2024-11: 0 reports for this device; peer average 3.28/device2024-12: 0 reports for this device; peer average 2.28/device2025-01: 0 reports for this device; peer average 6.46/device2025-02: 0 reports for this device; peer average 6.95/device2025-03: 0 reports for this device; peer average 2.59/device2025-04: 0 reports for this device; peer average 2.5/device2025-05: 0 reports for this device; peer average 2.48/device2025-06: 0 reports for this device; peer average 2.89/device2025-07: 0 reports for this device; peer average 3.11/device2025-08: 0 reports for this device; peer average 4.05/device2025-09: 0 reports for this device; peer average 2.85/device2025-10: 0 reports for this device; peer average 9.4/device2025-11: 0 reports for this device; peer average 3.08/device2025-12: 0 reports for this device; peer average 6.56/device2026-01: 0 reports for this device; peer average 7.11/device2026-02: 0 reports for this device; peer average 4.38/device2026-03: 0 reports for this device; peer average 16.38/device2026-04: 0 reports for this device; peer average 12.28/device2026-05: 0 reports for this device; peer average 19.41/device2026-06: 0 reports for this device; peer average 10.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0105
2019-02011.5
2019-0308.71
2019-0407.44
2019-05015.67
2019-06011
2019-07012.6
2019-08024.67
2019-0909.5
2019-1009
2019-1109.5
2019-12013.67
2020-0104.38
2020-02010.4
2020-0309.75
2020-04014.75
2020-0506
2020-0602.6
2020-0703.6
2020-0803.38
2020-0901.87
2020-1003.22
2020-1102.36
2020-1203.4
2021-0102.91
2021-0203
2021-0303.5
2021-0403.5
2021-0504
2021-0603.08
2021-0704.58
2021-0804
2021-0902.5
2021-1003.58
2021-1103.45
2021-1204.5
2022-0103.29
2022-0202.8
2022-0303.67
2022-0402.15
2022-0501.78
2022-0604
2022-0702.83
2022-0802.7
2022-0902.75
2022-1003.33
2022-1102.18
2022-1202.13
2023-0102.27
2023-0202.42
2023-0302.47
2023-0402.28
2023-0501.56
2023-0602.85
2023-0702.75
2023-0802.11
2023-0902.05
2023-1003.58
2023-1102.22
2023-1201.91
2024-0102.07
2024-0202.76
2024-0302.75
2024-0404.72
2024-0502.61
2024-0602.58
2024-0703.05
2024-0803.33
2024-0903.33
2024-1003.42
2024-1103.28
2024-1202.28
2025-0106.46
2025-0206.95
2025-0302.59
2025-0402.5
2025-0502.48
2025-0602.89
2025-0703.11
2025-0804.05
2025-0902.85
2025-1009.4
2025-1103.08
2025-1206.56
2026-0107.11
2026-0204.38
2026-03016.38
2026-04012.28
2026-05019.41
2026-06010.38
This device (reports/month)Average device in LLZ (reports/device/month)

Regulatory clearances

  • K213975 SESE 2022-05-06 (k number procode)

Predicate lineage

K213975 — cites (transitively): K141669 (d1), K180091 (d1), K073714 (d2), K111019 (d2), K083810 (d2), K163595 (d2), K170172 (d2), K072226 (d3), K083798 (d3), K121760 (d3), K150481 (d3), K151214 (d3), K120368 (d4), K082698 (d4), K100945 (d4), K110843 (d4), K112316 (d4), K113138 (d4), K113561 (d4), K130699 (d4), K133614 (d4), K141405 (d4), K071795 (d4), K073109 (d4), K100043 (d4), K120918 (d4), K123045 (d4), K141942 (d4), K080401 (d5), K051454 (d5), K063399 (d5), K080024 (d5), K080699 (d5), K083626 (d5), K083894 (d5), P960025 (d5), K073202 (d5), K033926 (d5), K073291 (d5), K090353 (d5), K094025 (d5), K103731 (d5), K031672 (d5), K103169 (d5), K101302 (d5), K071724 (d5), K081968 (d5), K100089 (d5), K131372 (d5), K101301 (d5), K101310 (d5), K102090 (d5), K111122 (d5), K133200 (d5), K133286 (d5), P950002 (d6), K052261 (d6), P950019 (d6), K081917 (d6), K083186 (d6), K090064 (d6), K072415 (d6), K003836 (d7), K010930 (d7) — cited as predicate by K213579, K223841, K260322

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

Manufacturer compliance record — S.M.A.I.O

  • VAI 2024-09-19 S.M.A.I.O · 1 citations
  • VAI 2024-09-19 S.M.A.I.O · 1 citations