LOGIQ
Model S8 R1 to R2 UPG · GE Ultrasound Korea Ltd. · DI 00840682117821
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
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 | 3.15 |
| 2019-02 | 0 | 5.46 |
| 2019-03 | 0 | 5.81 |
| 2019-04 | 0 | 3.3 |
| 2019-05 | 0 | 5.27 |
| 2019-06 | 0 | 6.28 |
| 2019-07 | 0 | 5.59 |
| 2019-08 | 0 | 7.45 |
| 2019-09 | 0 | 3.92 |
| 2019-10 | 0 | 3.57 |
| 2019-11 | 0 | 4.04 |
| 2019-12 | 0 | 4.84 |
| 2020-01 | 0 | 2.75 |
| 2020-02 | 0 | 5.41 |
| 2020-03 | 0 | 5.5 |
| 2020-04 | 0 | 5.17 |
| 2020-05 | 0 | 2.89 |
| 2020-06 | 0 | 3.16 |
| 2020-07 | 0 | 4.32 |
| 2020-08 | 0 | 2.93 |
| 2020-09 | 0 | 2.07 |
| 2020-10 | 0 | 3.79 |
| 2020-11 | 0 | 4.01 |
| 2020-12 | 0 | 5.87 |
| 2021-01 | 0 | 6.53 |
| 2021-02 | 0 | 4.61 |
| 2021-03 | 0 | 7.44 |
| 2021-04 | 0 | 4.17 |
| 2021-05 | 0 | 5.98 |
| 2021-06 | 0 | 6.44 |
| 2021-07 | 0 | 8.34 |
| 2021-08 | 0 | 7.22 |
| 2021-09 | 0 | 9.35 |
| 2021-10 | 0 | 5.7 |
| 2021-11 | 0 | 6.88 |
| 2021-12 | 0 | 9.64 |
| 2022-01 | 0 | 6.49 |
| 2022-02 | 0 | 8.37 |
| 2022-03 | 0 | 7.24 |
| 2022-04 | 0 | 8.11 |
| 2022-05 | 0 | 9.67 |
| 2022-06 | 0 | 7.56 |
| 2022-07 | 0 | 7.46 |
| 2022-08 | 0 | 5.42 |
| 2022-09 | 0 | 4.73 |
| 2022-10 | 0 | 4.62 |
| 2022-11 | 0 | 4.41 |
| 2022-12 | 0 | 5.16 |
| 2023-01 | 0 | 5.01 |
| 2023-02 | 0 | 4.61 |
| 2023-03 | 0 | 5.75 |
| 2023-04 | 0 | 3.78 |
| 2023-05 | 0 | 6.15 |
| 2023-06 | 0 | 4.06 |
| 2023-07 | 0 | 4.25 |
| 2023-08 | 0 | 5.94 |
| 2023-09 | 0 | 5.7 |
| 2023-10 | 0 | 6.69 |
| 2023-11 | 0 | 5.36 |
| 2023-12 | 0 | 5.47 |
| 2024-01 | 0 | 6.28 |
| 2024-02 | 0 | 4.31 |
| 2024-03 | 0 | 5.97 |
| 2024-04 | 0 | 5.86 |
| 2024-05 | 0 | 4.16 |
| 2024-06 | 0 | 5.85 |
| 2024-07 | 0 | 4.97 |
| 2024-08 | 0 | 5.4 |
| 2024-09 | 0 | 5.79 |
| 2024-10 | 0 | 6.4 |
| 2024-11 | 0 | 4.03 |
| 2024-12 | 0 | 11.27 |
| 2025-01 | 0 | 4.34 |
| 2025-02 | 0 | 4.03 |
| 2025-03 | 0 | 5.83 |
| 2025-04 | 0 | 3.25 |
| 2025-05 | 0 | 3.93 |
| 2025-06 | 0 | 4.11 |
| 2025-07 | 0 | 4.1 |
| 2025-08 | 0 | 5.45 |
| 2025-09 | 0 | 6.52 |
| 2025-10 | 0 | 9.71 |
| 2025-11 | 0 | 12.53 |
| 2025-12 | 0 | 18.81 |
| 2026-01 | 0 | 11.99 |
| 2026-02 | 0 | 6.63 |
| 2026-03 | 0 | 8.63 |
| 2026-04 | 0 | 11.88 |
| 2026-05 | 0 | 16.78 |
| 2026-06 | 0 | 15.26 |
Regulatory clearances
- K152195 SESE 2015-09-29 (k number procode)
Predicate lineage
K152195 — cites (transitively): K131514 (d1), K131527 (d1), K141261 (d1), K142160 (d1), K143452 (d1), K031663 (d2), K120201 (d2), K120221 (d2), K123564 (d2), K101874 (d2), K132274 (d2), K133034 (d2), K133533 (d2), K141639 (d2), K073297 (d3), K092271 (d3), K102388 (d3), K111582 (d3), K122327 (d3), K122921 (d3), K112255 (d3), K121329 (d3), K120741 (d3), K132913 (d3), K033139 (d4), K092079 (d4), K091970 (d4), K102041 (d4), K053435 (d4), K103649 (d4), K072786 (d4), K093563 (d4), K021966 (d5), K023877 (d5), K030455 (d5), K042540 (d5) — cited as predicate by K160182, K170445
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GE Ultrasound Korea Ltd.
- NAI 2011-11-17 GE ULTRASOUND KOREA, LTD. · 0 citations