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Lumen AirShuttle
Model XT-5100-80 · Qfix · DI 00841962120388
FRZ — Device, Patient Transfer, Powered · Class II · 21 CFR 880.6775
IYE — Accelerator, Linear, Medical · Class II · 21 CFR 892.5050
IZI — System, X-Ray, Angiographic · Class II · 21 CFR 892.1600
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
OWB — Interventional Fluoroscopic X-Ray System · Class II · 21 CFR 892.1650
UDILibrary device dossier · generated 2026-09-12 · 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
7.08
2019-02
0
4.7
2019-03
0
5.28
2019-04
0
7.77
2019-05
0
5.22
2019-06
0
4.83
2019-07
0
5
2019-08
0
5.48
2019-09
0
4.71
2019-10
0
4.05
2019-11
0
3.97
2019-12
0
5.09
2020-01
0
4.06
2020-02
0
4.61
2020-03
0
4.83
2020-04
0
6.58
2020-05
0
4.76
2020-06
0
4.44
2020-07
0
3.59
2020-08
0
3.5
2020-09
0
3.4
2020-10
0
3.62
2020-11
0
3.43
2020-12
0
3.43
2021-01
0
3.18
2021-02
0
3.61
2021-03
0
3.78
2021-04
0
4.92
2021-05
0
4.81
2021-06
0
6.09
2021-07
0
3.93
2021-08
0
5.65
2021-09
0
6.32
2021-10
0
4.63
2021-11
0
5.33
2021-12
0
5.55
2022-01
0
4.21
2022-02
0
4.39
2022-03
0
5.05
2022-04
0
4.83
2022-05
0
7.08
2022-06
0
4.69
2022-07
0
5.1
2022-08
0
5.09
2022-09
0
5.1
2022-10
0
18.35
2022-11
0
34.43
2022-12
0
34.36
2023-01
0
45.69
2023-02
0
29.82
2023-03
0
55.08
2023-04
0
36.14
2023-05
0
36.27
2023-06
0
29.21
2023-07
0
21.11
2023-08
0
24.93
2023-09
0
36.22
2023-10
0
31.24
2023-11
0
40.03
2023-12
0
36.92
2024-01
0
37.6
2024-02
0
54.37
2024-03
0
36.79
2024-04
0
31.18
2024-05
0
31.36
2024-06
0
33.41
2024-07
0
34.05
2024-08
0
44.18
2024-09
0
42.37
2024-10
0
36.16
2024-11
0
27.92
2024-12
0
30.19
2025-01
0
28.87
2025-02
0
39.71
2025-03
0
27.1
2025-04
0
56.31
2025-05
0
50.85
2025-06
0
48.13
2025-07
0
50.05
2025-08
0
73.25
2025-09
0
109.97
2025-10
0
108.77
2025-11
0
74.25
2025-12
0
26.06
2026-01
0
27.42
2026-02
0
18.04
2026-03
0
20.73
2026-04
0
16.31
2026-05
0
19.57
2026-06
0
15.75
This device (reports/month)Average device in FRZ, IYE, IZI, JAI, JAK, KPS, LHN, LNH, OUO, OWB (reports/device/month)