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Senographe Pristina 3D

Model ATA1 · GE MEDICAL SYSTEMS · DI 00840682120142

OTE — Digital Breast Tomosynthesis · Class III

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.

4812162019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.67/device2020-03: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 4/device2021-12: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 4.33/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 6/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 2.5/device2022-11: 0 reports for this device; peer average 3.5/device2022-12: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 3.33/device2023-04: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 5/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 7/device2024-03: 0 reports for this device; peer average 5.5/device2024-04: 0 reports for this device; peer average 3.5/device2024-05: 0 reports for this device; peer average 5/device2024-06: 0 reports for this device; peer average 5.5/device2024-07: 0 reports for this device; peer average 5.67/device2024-08: 0 reports for this device; peer average 6.33/device2024-09: 0 reports for this device; peer average 4.5/device2024-10: 0 reports for this device; peer average 2.5/device2024-11: 0 reports for this device; peer average 6.25/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 4/device2025-04: 0 reports for this device; peer average 7.75/device2025-05: 0 reports for this device; peer average 16/device2025-06: 0 reports for this device; peer average 4.2/device2025-07: 0 reports for this device; peer average 10/device2025-08: 0 reports for this device; peer average 3.33/device2025-09: 0 reports for this device; peer average 6.33/device2025-10: 0 reports for this device; peer average 3.75/device2025-11: 0 reports for this device; peer average 3.75/device2025-12: 0 reports for this device; peer average 4.25/device2026-01: 0 reports for this device; peer average 4/device2026-02: 0 reports for this device; peer average 7.33/device2026-03: 0 reports for this device; peer average 7/device2026-04: 0 reports for this device; peer average 6.5/device2026-05: 0 reports for this device; peer average 5.29/device2026-06: 0 reports for this device; peer average 8.75/device010204050607080911120102030607080912020507080911120203040506080910111201020304060809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0202
2019-0402
2019-0503
2019-0602
2019-0702
2019-0802
2019-0902
2019-1103
2019-1202
2020-0102
2020-0202.67
2020-0302
2020-0602
2020-0702
2020-0802
2020-0902
2020-1202
2021-0202
2021-0502
2021-0702
2021-0802
2021-0904
2021-1104
2021-1202
2022-0202
2022-0304.33
2022-0403
2022-0501.5
2022-0603
2022-0806
2022-0903
2022-1002.5
2022-1103.5
2022-1203
2023-0103
2023-0202
2023-0303.33
2023-0402
2023-0602
2023-0801.5
2023-0902
2023-1002
2023-1105
2023-1204
2024-0101.5
2024-0207
2024-0305.5
2024-0403.5
2024-0505
2024-0605.5
2024-0705.67
2024-0806.33
2024-0904.5
2024-1002.5
2024-1106.25
2024-1204
2025-0102
2025-0203
2025-0304
2025-0407.75
2025-05016
2025-0604.2
2025-07010
2025-0803.33
2025-0906.33
2025-1003.75
2025-1103.75
2025-1204.25
2026-0104
2026-0207.33
2026-0307
2026-0406.5
2026-0505.29
2026-0608.75
This device (reports/month)Average device in OTE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — GE MEDICAL SYSTEMS

  • NAI 2022-09-29 GE Medical Systems, LLC · 0 citations
  • VAI 2018-06-14 GE Medical Systems, LLC · 0 citations
  • NAI 2016-10-11 GE MEDICAL SYSTEMS, LLC · 0 citations
  • NAI 2014-11-10 GE Medical Systems, LLC · 0 citations
  • VAI 2014-02-28 GE Medical Systems, LLC · 1 citations
  • VAI 2013-06-17 GE Medical Systems, LLC · 1 citations
  • NAI 2012-10-11 GE Medical Systems, LLC · 0 citations
  • VAI 2012-03-02 GE Medical Systems, LLC · 7 citations
  • VAI 2011-01-11 GE Medical Systems, LLC · 3 citations
  • NAI 2010-04-26 GE Medical Systems, LLC · 0 citations
  • NAI 2010-01-29 GE Medical Systems, LLC · 0 citations