C60XI/5-2 MHZ
Model P24538-01 · FUJIFILM SONOSITE, INC. · DI 00841517108151
ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.65 |
| 2019-02 | 0 | 4.85 |
| 2019-03 | 0 | 4.67 |
| 2019-04 | 0 | 3.17 |
| 2019-05 | 0 | 4.17 |
| 2019-06 | 0 | 5.17 |
| 2019-07 | 0 | 4.81 |
| 2019-08 | 0 | 5.87 |
| 2019-09 | 0 | 2.97 |
| 2019-10 | 0 | 3.17 |
| 2019-11 | 0 | 3.54 |
| 2019-12 | 0 | 4.79 |
| 2020-01 | 0 | 2.53 |
| 2020-02 | 0 | 3.88 |
| 2020-03 | 0 | 4.8 |
| 2020-04 | 0 | 4.04 |
| 2020-05 | 0 | 2.48 |
| 2020-06 | 0 | 3.1 |
| 2020-07 | 0 | 4.05 |
| 2020-08 | 0 | 2.73 |
| 2020-09 | 0 | 1.97 |
| 2020-10 | 0 | 3.78 |
| 2020-11 | 0 | 3.47 |
| 2020-12 | 0 | 4.78 |
| 2021-01 | 0 | 5.15 |
| 2021-02 | 0 | 4.14 |
| 2021-03 | 0 | 5.71 |
| 2021-04 | 0 | 3.63 |
| 2021-05 | 0 | 5 |
| 2021-06 | 0 | 4.98 |
| 2021-07 | 0 | 6.52 |
| 2021-08 | 0 | 5.93 |
| 2021-09 | 0 | 7.41 |
| 2021-10 | 0 | 5.72 |
| 2021-11 | 0 | 5.41 |
| 2021-12 | 0 | 7.97 |
| 2022-01 | 0 | 5.5 |
| 2022-02 | 0 | 7.74 |
| 2022-03 | 0 | 6.18 |
| 2022-04 | 0 | 6.57 |
| 2022-05 | 0 | 7.45 |
| 2022-06 | 0 | 6.17 |
| 2022-07 | 0 | 5.91 |
| 2022-08 | 0 | 5.09 |
| 2022-09 | 0 | 4.74 |
| 2022-10 | 0 | 4.43 |
| 2022-11 | 0 | 4.38 |
| 2022-12 | 0 | 4.81 |
| 2023-01 | 0 | 5.11 |
| 2023-02 | 0 | 4.55 |
| 2023-03 | 0 | 4.97 |
| 2023-04 | 0 | 3.69 |
| 2023-05 | 0 | 5.94 |
| 2023-06 | 0 | 4 |
| 2023-07 | 0 | 4.12 |
| 2023-08 | 0 | 5.33 |
| 2023-09 | 0 | 5.39 |
| 2023-10 | 0 | 6.24 |
| 2023-11 | 0 | 4.53 |
| 2023-12 | 0 | 4.9 |
| 2024-01 | 0 | 5.69 |
| 2024-02 | 0 | 4.3 |
| 2024-03 | 0 | 5.32 |
| 2024-04 | 0 | 5.47 |
| 2024-05 | 0 | 4.08 |
| 2024-06 | 0 | 5.54 |
| 2024-07 | 0 | 4.78 |
| 2024-08 | 0 | 5.3 |
| 2024-09 | 0 | 5.27 |
| 2024-10 | 0 | 5.75 |
| 2024-11 | 0 | 3.89 |
| 2024-12 | 0 | 9.38 |
| 2025-01 | 0 | 4 |
| 2025-02 | 0 | 3.85 |
| 2025-03 | 0 | 6.11 |
| 2025-04 | 0 | 3.21 |
| 2025-05 | 0 | 4.2 |
| 2025-06 | 0 | 4.15 |
| 2025-07 | 0 | 4.17 |
| 2025-08 | 0 | 5.65 |
| 2025-09 | 0 | 6.56 |
| 2025-10 | 0 | 9.4 |
| 2025-11 | 0 | 11.48 |
| 2025-12 | 0 | 16.54 |
| 2026-01 | 0 | 10.77 |
| 2026-02 | 0 | 6.4 |
| 2026-03 | 0 | 8.18 |
| 2026-04 | 0 | 10.63 |
| 2026-05 | 0 | 15.69 |
| 2026-06 | 0 | 14.42 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K071134 — cited as predicate by K101757, K102390, K113156, K133454, K150148
K082098 — cited as predicate by K101757, K102390, K112067, K113156, K130173, K133454, K150148, K150533
K101757 — cites (transitively): K043559 (d1), K071134 (d1), K082098 (d1), K092058 (d1) — cited as predicate by K113647, K130173, K132228, K163020
K130173 — cites (transitively): K082098 (d1), K101757 (d1), K112953 (d1), K113156 (d1), K043559 (d2), K071134 (d2), K092058 (d2), K010883 (d2), K012191 (d2), K030191 (d2), K040840 (d2), K043278 (d2), K080234 (d2), K992505 (d2) — cited as predicate by K133454, K160734, K202160
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — FUJIFILM SONOSITE, INC.
- NAI 2012-07-06 FujiFilm SonoSite, Inc. · 0 citations
- NAI 2010-04-02 FujiFilm SonoSite, Inc. · 0 citations