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Model RT-5100-11 · Qfix · DI 00841962119535
FRZ — Device, Patient Transfer, Powered · Class II · 21 CFR 880.6775
IYE — Accelerator, Linear, Medical · Class II · 21 CFR 892.5050
JAI — Couch, Radiation Therapy, Powered · Class II · 21 CFR 892.5770
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
KPS — System, Tomography, Computed, Emission · Class II · 21 CFR 892.1200
LHN — System, Radiation Therapy, Charged-Particle, Medical · Class II · 21 CFR 892.5050
LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000
OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance · Class II · 21 CFR 892.1200
UDILibrary device dossier · generated 2026-09-13 · 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
5.1
2019-02
0
2.92
2019-03
0
3
2019-04
0
4.74
2019-05
0
2.55
2019-06
0
2.5
2019-07
0
2.38
2019-08
0
1.92
2019-09
0
2.22
2019-10
0
2.15
2019-11
0
1.54
2019-12
0
4.47
2020-01
0
2.41
2020-02
0
2.38
2020-03
0
1.92
2020-04
0
3.17
2020-05
0
2.79
2020-06
0
2.31
2020-07
0
1.97
2020-08
0
2.16
2020-09
0
1.9
2020-10
0
2.29
2020-11
0
2.26
2020-12
0
2.5
2021-01
0
1.71
2021-02
0
1.93
2021-03
0
2.21
2021-04
0
2.59
2021-05
0
3.3
2021-06
0
4.15
2021-07
0
3.05
2021-08
0
2.38
2021-09
0
2.17
2021-10
0
1.5
2021-11
0
2.48
2021-12
0
3.1
2022-01
0
1.73
2022-02
0
2.14
2022-03
0
2.26
2022-04
0
1.97
2022-05
0
1.62
2022-06
0
2.1
2022-07
0
3.12
2022-08
0
1.89
2022-09
0
2.53
2022-10
0
1.7
2022-11
0
2.13
2022-12
0
1.47
2023-01
0
2.75
2023-02
0
1.9
2023-03
0
2.91
2023-04
0
4.96
2023-05
0
3.05
2023-06
0
5.36
2023-07
0
2.22
2023-08
0
3.07
2023-09
0
2.71
2023-10
0
3.79
2023-11
0
2.46
2023-12
0
2.36
2024-01
0
1.52
2024-02
0
1.63
2024-03
0
1.73
2024-04
0
1.65
2024-05
0
2
2024-06
0
2.23
2024-07
0
1.72
2024-08
0
1.35
2024-09
0
1.22
2024-10
0
1.76
2024-11
0
1.69
2024-12
0
1.4
2025-01
0
3.2
2025-02
0
2.5
2025-03
0
1.91
2025-04
0
1.9
2025-05
0
2.43
2025-06
0
3.79
2025-07
0
3.91
2025-08
0
4.55
2025-09
0
3.62
2025-10
0
3.94
2025-11
0
2.92
2025-12
0
4.85
2026-01
0
4.36
2026-02
0
2.9
2026-03
0
2.95
2026-04
0
3.1
2026-05
0
4.7
2026-06
0
2.28
This device (reports/month)Average device in FRZ, IYE, JAI, JAK, KPS, LHN, LNH, OUO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K160627 — cites (transitively): K121929 (d1) — cited as predicate by K182189, K230312
Lineage extracted from public 510(k) summary text (heuristic).