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Model H3908AM · GE Medical Systems Israel, Functional Imaging · DI 00840682145473
ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570
IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550
IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.48 |
| 2019-02 | 0 | 5.02 |
| 2019-03 | 0 | 4.95 |
| 2019-04 | 0 | 3.93 |
| 2019-05 | 0 | 4.83 |
| 2019-06 | 0 | 5.66 |
| 2019-07 | 0 | 4.8 |
| 2019-08 | 0 | 6.67 |
| 2019-09 | 0 | 3.72 |
| 2019-10 | 0 | 3.35 |
| 2019-11 | 0 | 3.79 |
| 2019-12 | 0 | 4.93 |
| 2020-01 | 0 | 2.61 |
| 2020-02 | 0 | 4.68 |
| 2020-03 | 0 | 5.16 |
| 2020-04 | 0 | 5.09 |
| 2020-05 | 0 | 2.77 |
| 2020-06 | 0 | 3.07 |
| 2020-07 | 0 | 3.95 |
| 2020-08 | 0 | 2.7 |
| 2020-09 | 0 | 2.04 |
| 2020-10 | 0 | 3.42 |
| 2020-11 | 0 | 3.7 |
| 2020-12 | 0 | 5.43 |
| 2021-01 | 0 | 5.79 |
| 2021-02 | 0 | 4.07 |
| 2021-03 | 0 | 6.37 |
| 2021-04 | 0 | 3.86 |
| 2021-05 | 0 | 5.54 |
| 2021-06 | 0 | 6.06 |
| 2021-07 | 0 | 7.53 |
| 2021-08 | 0 | 6.4 |
| 2021-09 | 0 | 7.47 |
| 2021-10 | 0 | 5.11 |
| 2021-11 | 0 | 6.04 |
| 2021-12 | 0 | 8.16 |
| 2022-01 | 0 | 5.57 |
| 2022-02 | 0 | 6.95 |
| 2022-03 | 0 | 6.26 |
| 2022-04 | 0 | 7.17 |
| 2022-05 | 0 | 8.67 |
| 2022-06 | 0 | 6.09 |
| 2022-07 | 0 | 6.6 |
| 2022-08 | 0 | 4.57 |
| 2022-09 | 0 | 4.22 |
| 2022-10 | 0 | 4.34 |
| 2022-11 | 0 | 4.04 |
| 2022-12 | 0 | 4.51 |
| 2023-01 | 0 | 4.63 |
| 2023-02 | 0 | 4.19 |
| 2023-03 | 0 | 5.15 |
| 2023-04 | 0 | 3.62 |
| 2023-05 | 0 | 5.22 |
| 2023-06 | 0 | 4.62 |
| 2023-07 | 0 | 3.85 |
| 2023-08 | 0 | 5.21 |
| 2023-09 | 0 | 5.09 |
| 2023-10 | 0 | 6.53 |
| 2023-11 | 0 | 4.86 |
| 2023-12 | 0 | 4.84 |
| 2024-01 | 0 | 5.72 |
| 2024-02 | 0 | 3.95 |
| 2024-03 | 0 | 5.1 |
| 2024-04 | 0 | 5.03 |
| 2024-05 | 0 | 3.81 |
| 2024-06 | 0 | 5.5 |
| 2024-07 | 0 | 4.53 |
| 2024-08 | 0 | 4.94 |
| 2024-09 | 0 | 5.32 |
| 2024-10 | 0 | 5.66 |
| 2024-11 | 0 | 3.63 |
| 2024-12 | 0 | 10 |
| 2025-01 | 0 | 3.95 |
| 2025-02 | 0 | 3.69 |
| 2025-03 | 0 | 5 |
| 2025-04 | 0 | 3.1 |
| 2025-05 | 0 | 3.85 |
| 2025-06 | 0 | 3.87 |
| 2025-07 | 0 | 3.88 |
| 2025-08 | 0 | 5.04 |
| 2025-09 | 0 | 6.09 |
| 2025-10 | 0 | 8.97 |
| 2025-11 | 0 | 11.3 |
| 2025-12 | 0 | 17.29 |
| 2026-01 | 0 | 11.49 |
| 2026-02 | 0 | 6.09 |
| 2026-03 | 0 | 8.17 |
| 2026-04 | 0 | 10.78 |
| 2026-05 | 0 | 15.32 |
| 2026-06 | 0 | 12.84 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K173816 — cites (transitively): K093514 (d1), K121019 (d1), K153355 (d1), K171013 (d1), K021491 (d2), K052434 (d2), K093982 (d2), K101279 (d2), K103480 (d2), K130884 (d2), K141074 (d2), K123596 (d2), K051673 (d3), K003437 (d3), K023190 (d3), K063762 (d3), K080575 (d3), K083327 (d3), K082816 (d3), K021656 (d3), K062393 (d3), K110834 (d3) — cited as predicate by K210173, 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