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CARESTREAM CR Mammography Cassette with SNP-M1 Screen

Model CARESTREAM CR Mammography Cassette with SNP-M1 Screen · CARESTREAM HEALTH, INC. · DI 40889971941509

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

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.

23562019-02: 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 1.5/device2019-11: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.5/device2020-03: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 3/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/device2021-01: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 6/device2022-01: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 2.5/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 2.33/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1.5/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-08: 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 1.5/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 6/device2026-04: 0 reports for this device; peer average 1/device020506070811120102030709101112010509110104050607080102030607080910111203050608091205020304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0202
2019-0503
2019-0602
2019-0702
2019-0801.5
2019-1102
2019-1201
2020-0102
2020-0202.5
2020-0301
2020-0703
2020-0902
2020-1002
2020-1103
2020-1201
2021-0102
2021-0501
2021-0901
2021-1106
2022-0103
2022-0402.5
2022-0503
2022-0602.33
2022-0702
2022-0801
2023-0101.5
2023-0201
2023-0303
2023-0601
2023-0701
2023-0803
2023-0903
2023-1001.5
2023-1102
2023-1201
2024-0301
2024-0501
2024-0601
2024-0801
2024-0901
2024-1201
2025-0503
2026-0201
2026-0306
2026-0401
This device (reports/month)Average device in MUE (reports/device/month)

Regulatory clearances

  • K120246 SESE 2012-08-28 (k number procode)

Manufacturer compliance record — CARESTREAM HEALTH, INC.

  • NAI 2022-10-20 Carestream Health, Inc. · 0 citations
  • NAI 2022-10-20 Carestream Health, Inc. · 0 citations
  • NAI 2022-08-23 Carestream Health, Inc. · 0 citations
  • NAI 2022-08-23 Carestream Health, Inc. · 0 citations
  • NAI 2020-01-27 Carestream Health, Inc. · 0 citations
  • NAI 2020-01-27 Carestream Health, Inc. · 0 citations
  • NAI 2019-04-09 Carestream Health, Inc. · 0 citations
  • NAI 2019-04-09 Carestream Health, Inc. · 0 citations
  • VAI 2018-08-15 Carestream Health, Inc. · 3 citations
  • VAI 2018-08-15 Carestream Health, Inc. · 3 citations
  • VAI 2018-01-16 Carestream Health, Inc., Global R&D Center (Shanghai) · 0 citations
  • NAI 2017-11-30 Carestream Health, Inc · 0 citations
  • NAI 2017-11-02 Carestream Health, Inc. · 0 citations
  • VAI 2017-03-23 Carestream Health, Inc. · 7 citations
  • VAI 2016-06-30 Carestream Health, Inc. · 0 citations
  • VAI 2016-06-30 Carestream Health, Inc. · 0 citations
  • VAI 2013-06-05 Carestream Health, Inc. · 0 citations
  • VAI 2013-06-05 Carestream Health, Inc. · 0 citations
  • NAI 2012-11-06 Carestream Health, Inc · 0 citations
  • NAI 2012-10-19 Carestream Health, Inc · 0 citations