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Model H3906DT · GE Medical Systems Israel, Functional Imaging · DI 00840682145459
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
KPS — System, Tomography, Computed, Emission · Class II · 21 CFR 892.1200
UDILibrary device dossier · generated 2026-09-14 · 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
3.3
2019-03
0
3.15
2019-04
0
5.74
2019-05
0
3.31
2019-06
0
2.8
2019-07
0
2.58
2019-08
0
2.38
2019-09
0
2.14
2019-10
0
2.25
2019-11
0
1.86
2019-12
0
5.33
2020-01
0
1.92
2020-02
0
2.75
2020-03
0
2.17
2020-04
0
3.67
2020-05
0
2
2020-06
0
2.44
2020-07
0
2.25
2020-08
0
1.74
2020-09
0
1.95
2020-10
0
2.05
2020-11
0
2.24
2020-12
0
2.4
2021-01
0
1.47
2021-02
0
1.82
2021-03
0
2.43
2021-04
0
2.74
2021-05
0
3.77
2021-06
0
4.55
2021-07
0
3.07
2021-08
0
2.53
2021-09
0
2.3
2021-10
0
1.67
2021-11
0
2.62
2021-12
0
2.75
2022-01
0
1.89
2022-02
0
2.47
2022-03
0
2.43
2022-04
0
2.45
2022-05
0
1.73
2022-06
0
1.88
2022-07
0
3.53
2022-08
0
1.86
2022-09
0
2.81
2022-10
0
2.09
2022-11
0
2.07
2022-12
0
1.65
2023-01
0
2.31
2023-02
0
1.9
2023-03
0
2.63
2023-04
0
2.17
2023-05
0
2.57
2023-06
0
6.62
2023-07
0
2.1
2023-08
0
3.42
2023-09
0
2.95
2023-10
0
5.89
2023-11
0
2.58
2023-12
0
2.74
2024-01
0
1.9
2024-02
0
1.88
2024-03
0
1.85
2024-04
0
1.72
2024-05
0
2.24
2024-06
0
3.08
2024-07
0
1.88
2024-08
0
1.33
2024-09
0
1.17
2024-10
0
1.95
2024-11
0
1.45
2024-12
0
1.69
2025-01
0
1.59
2025-02
0
1.58
2025-03
0
1.39
2025-04
0
1.86
2025-05
0
2.5
2025-06
0
1.5
2025-07
0
1.5
2025-08
0
1.5
2025-09
0
1.67
2025-10
0
1.08
2025-11
0
1.28
2025-12
0
2.33
2026-01
0
2.22
2026-02
0
1.68
2026-03
0
1.45
2026-04
0
2
2026-05
0
2.19
2026-06
0
1.55
This device (reports/month)Average device in JAK, KPS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K093514 — cited as predicate by K153402, K173816, K243605
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GE Medical Systems Israel, Functional Imaging
NAI 2010-01-12 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · 0 citations