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Not Applicable

Model PRISTINA 2.9 · GE MEDICAL SYSTEMS · DI 10195278901764

MUE — Full Field Digital, System, X-Ray, Mammographic · Class II · 21 CFR 892.1715

OTE — Digital Breast Tomosynthesis · Class III

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 (2)

InitiatedRecall #ClassStatusReasonLink basis
2025-10-24Z-0875-2026Class IIOpen, ClassifiedSome Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).k number procode
2023-12-26Z-0862-2024Class IIOpen, ClassifiedX-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.k number procode

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.

358102019-01: 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 1.75/device2019-09: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 2.67/device2019-12: 0 reports for this device; peer average 1.8/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.6/device2020-03: 0 reports for this device; peer average 1.75/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 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 1.5/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 2.5/device2021-11: 0 reports for this device; peer average 5/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 3/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 2.67/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 3.5/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 2/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 3.25/device2023-04: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1.5/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 2.5/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 3.5/device2023-12: 0 reports for this device; peer average 3/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 3.25/device2024-04: 0 reports for this device; peer average 3.5/device2024-05: 0 reports for this device; peer average 4/device2024-06: 0 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 5.67/device2024-08: 0 reports for this device; peer average 5/device2024-09: 0 reports for this device; peer average 3.8/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 3.25/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 9.5/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 4.8/device2026-03: 0 reports for this device; peer average 6.67/device2026-04: 0 reports for this device; peer average 5.4/device2026-05: 0 reports for this device; peer average 5.29/device2026-06: 0 reports for this device; peer average 8.75/device010204050607080911120102030607080910111201020507080911120102030405060708091011120102030406070809101112010203040506070809101112010203040506070809101112010203040506
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
2019-0801.75
2019-0902
2019-1102.67
2019-1201.8
2020-0102
2020-0202.6
2020-0301.75
2020-0602
2020-0702.5
2020-0802
2020-0902
2020-1002
2020-1103
2020-1201.33
2021-0102
2021-0202
2021-0501.5
2021-0702
2021-0802
2021-0902.5
2021-1105
2021-1202
2022-0103
2022-0202
2022-0304.33
2022-0402.67
2022-0502
2022-0602.5
2022-0702
2022-0803.5
2022-0903
2022-1002.5
2022-1103.5
2022-1203
2023-0102
2023-0201.5
2023-0303.25
2023-0402
2023-0601.5
2023-0701
2023-0802
2023-0902.5
2023-1001.67
2023-1103.5
2023-1203
2024-0101.5
2024-0207
2024-0303.25
2024-0403.5
2024-0504
2024-0604
2024-0705.67
2024-0805
2024-0903.8
2024-1002.5
2024-1106.25
2024-1203.25
2025-0102
2025-0203
2025-0304
2025-0407.75
2025-0509.5
2025-0604.2
2025-07010
2025-0803.33
2025-0906.33
2025-1003.75
2025-1103.75
2025-1204.25
2026-0104
2026-0204.8
2026-0306.67
2026-0405.4
2026-0505.29
2026-0608.75
This device (reports/month)Average device in MUE, OTE (reports/device/month)

Regulatory clearances

  • K211725 SESE 2021-08-06 (k number procode)
  • K211215 SESE 2021-06-22 (k number procode)
  • K193334 SESE 2020-05-15 (k number procode)
  • K182951 SESE 2019-01-18 (k number procode)

Predicate lineage

K162268 — cites (transitively): P990066 (d1) — cited as predicate by K163302, K172404, K173576, K193334, K211725

K173576 — cites (transitively): K040125 (d1), K162268 (d1), P990066 (d2) — cited as predicate by K182951, K190809, K193334, K260087

K182951 — cites (transitively): K122836 (d1), K161575 (d1), K173576 (d1), P130020 (d1), K103512 (d2), K040125 (d2), K162268 (d2), K071542 (d3), P990066 (d3)

K193334 — cites (transitively): K162268 (d1), K172404 (d1), K173576 (d1), P990066 (d2), K103485 (d2), K040125 (d2) — cited as predicate by K260087

K211215 — cites (transitively): K172404 (d1), K103485 (d2), K162268 (d2), P990066 (d3) — cited as predicate by K260087

K211725 — cites (transitively): K131885 (d1), K162268 (d1), K110798 (d2), P990066 (d2) — cited as predicate by K260087

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

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