Print-ready dossier — use your browser's print dialog to save as PDF.
.decimal Proton Shell and Lid Assembly
Model 2.3 · DECIMAL, INC. · DI 00851147007083
MUJ — System, Planning, Radiation Therapy Treatment · Class II · 21 CFR 892.5050
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-04
0
1
2019-05
0
1.14
2019-06
0
2.29
2019-07
0
1.14
2019-08
0
1.57
2019-09
0
1
2019-10
0
1
2019-11
0
1.14
2019-12
0
1
2020-02
0
1.14
2020-03
0
4.57
2020-04
0
2.29
2020-05
0
1.14
2020-07
0
2.13
2020-08
0
1
2020-09
0
1.14
2020-11
0
2
2021-07
0
2.29
2021-08
0
2.29
2021-10
0
1.71
2021-12
0
1.5
2022-01
0
1
2022-02
0
1
2022-03
0
1
2022-06
0
2
2022-08
0
1
2022-09
0
1
2022-11
0
1.33
2022-12
0
1.5
2023-01
0
1.14
2023-03
0
2.5
2023-04
0
1.67
2023-09
0
1
2023-10
0
1.2
2023-12
0
1
2024-03
0
1
2024-05
0
1
2024-10
0
1.5
2025-02
0
1
2025-04
0
1
2025-06
0
1
2025-08
0
1
2025-09
0
1
2025-10
0
2
2025-11
0
1
2025-12
0
1
2026-04
0
1
2026-06
0
1
This device (reports/month)Average device in MUJ (reports/device/month)