Print-ready dossier — use your browser's print dialog to save as PDF.
IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
Model SPINEL 3G · GEMSS MEDICAL SYSTEMS CO.,LTD. · DI 08809246620018
JAA — System, X-Ray, Fluoroscopic, Image-Intensified · Class II · 21 CFR 892.1650
OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile · 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
11.91
2019-02
0
7.07
2019-03
0
9.07
2019-04
0
12.24
2019-05
0
10.55
2019-06
0
7.93
2019-07
0
10.08
2019-08
0
10.31
2019-09
0
6.85
2019-10
0
6.84
2019-11
0
6.63
2019-12
0
7.59
2020-01
0
7.33
2020-02
0
8.2
2020-03
0
10.44
2020-04
0
8.25
2020-05
0
9
2020-06
0
7.4
2020-07
0
7.68
2020-08
0
7.07
2020-09
0
6.44
2020-10
0
6.77
2020-11
0
5.15
2020-12
0
4.96
2021-01
0
5.39
2021-02
0
5.97
2021-03
0
5.92
2021-04
0
7.12
2021-05
0
7.7
2021-06
0
8.27
2021-07
0
4.48
2021-08
0
8.97
2021-09
0
9.33
2021-10
0
7.47
2021-11
0
8.78
2021-12
0
7.5
2022-01
0
6.92
2022-02
0
6.66
2022-03
0
7.78
2022-04
0
7.17
2022-05
0
9.97
2022-06
0
7.15
2022-07
0
6.34
2022-08
0
7.4
2022-09
0
7.24
2022-10
0
17.12
2022-11
0
30.18
2022-12
0
29.42
2023-01
0
38.57
2023-02
0
26.15
2023-03
0
44.49
2023-04
0
29.66
2023-05
0
34.33
2023-06
0
28.76
2023-07
0
21.08
2023-08
0
23.21
2023-09
0
33.11
2023-10
0
28.4
2023-11
0
31.62
2023-12
0
36.06
2024-01
0
30.44
2024-02
0
45.48
2024-03
0
28.63
2024-04
0
29.87
2024-05
0
32.02
2024-06
0
26.31
2024-07
0
28.5
2024-08
0
37.7
2024-09
0
40.41
2024-10
0
33.55
2024-11
0
32.9
2024-12
0
34.43
2025-01
0
34.63
2025-02
0
42.28
2025-03
0
38.02
2025-04
0
43.75
2025-05
0
52
2025-06
0
46.9
2025-07
0
52.94
2025-08
0
67.69
2025-09
0
129.54
2025-10
0
107.08
2025-11
0
74.63
2025-12
0
36.76
2026-01
0
31.91
2026-02
0
23.96
2026-03
0
24.83
2026-04
0
23.71
2026-05
0
25.46
2026-06
0
20.71
This device (reports/month)Average device in JAA, OXO (reports/device/month)
Regulatory clearances
K132289 SESE 2014-06-16 (k number procode)
Predicate lineage
K132289 — cites (transitively): K032761 (d1)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GEMSS MEDICAL SYSTEMS CO.,LTD.