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AIDIA
Model RMF-2000 · DRTECH Corporation · DI 08800018423004
MUE — Full Field Digital, System, X-Ray, Mammographic · Class II · 21 CFR 892.1715
UDILibrary device dossier · generated 2026-09-11 · 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)
2019-02
0
2
2019-05
0
3
2019-06
0
2
2019-07
0
2
2019-08
0
1.5
2019-11
0
2
2019-12
0
1
2020-01
0
2
2020-02
0
2.5
2020-03
0
1
2020-07
0
3
2020-09
0
2
2020-10
0
2
2020-11
0
3
2020-12
0
1
2021-01
0
2
2021-05
0
1
2021-09
0
1
2021-11
0
6
2022-01
0
3
2022-04
0
2.5
2022-05
0
3
2022-06
0
2.33
2022-07
0
2
2022-08
0
1
2023-01
0
1.5
2023-02
0
1
2023-03
0
3
2023-06
0
1
2023-07
0
1
2023-08
0
3
2023-09
0
3
2023-10
0
1.5
2023-11
0
2
2023-12
0
1
2024-03
0
1
2024-05
0
1
2024-06
0
1
2024-08
0
1
2024-09
0
1
2024-12
0
1
2025-05
0
3
2026-02
0
1
2026-03
0
6
2026-04
0
1
This device (reports/month)Average device in MUE (reports/device/month)
Regulatory clearances
K220073 SESE 2023-01-26 (k number procode)
Predicate lineage
K220073 — cites (transitively): K110798 (d1), P010025 (d1), P990066 (d2) — cited as predicate by K254092
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — DRTECH Corporation