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AFFIRM™ CONTRAST BIOPSY
Model AFFIRM™ CONTRAST BIOPSY SOFTWARE · Hologic, Inc. · DI 15420045512948
IZH — System, X-Ray, Mammographic · Class II · 21 CFR 892.1710
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
6
2019-02
0
2.5
2019-03
0
4.5
2019-04
0
7
2019-05
0
4
2019-06
0
4
2019-07
0
3.5
2019-08
0
4.5
2019-09
0
3
2019-11
0
9
2019-12
0
3
2020-01
0
3
2020-02
0
3.67
2020-09
0
3
2021-02
0
1
2021-05
0
3
2021-09
0
3.5
2021-11
0
2
2022-01
0
2
2022-09
0
1
2022-10
0
1
2023-01
0
4
2023-02
0
2.5
2023-06
0
3
2024-02
0
3
2024-04
0
3
2024-08
0
3
2024-09
0
1
2025-02
0
2
2025-04
0
2.5
2025-08
0
2
2025-09
0
6
2025-10
0
9
2025-11
0
4.5
2025-12
0
3
2026-01
0
4
2026-02
0
6
2026-03
0
5.5
2026-04
0
2
2026-05
0
2
2026-06
0
3
This device (reports/month)Average device in IZH (reports/device/month)
Regulatory clearances
K103512 SESE 2011-01-07 (k number procode)
Predicate lineage
K103512 — cites (transitively): K071542 (d1) — cited as predicate by K122836, K202294
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Hologic, Inc.
Warning Letter 2024-12-18 Hologic, Inc
Warning Letter 2024-12-18 Hologic, Inc
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
VAI 2024-09-12 Hologic Surgical Products Costa Rica, S.R.L. · 0 citations