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pde-neo
Model C10935-40 · HAMAMATSU PHOTONICS K.K. · DI 04582389010093
IZI — System, X-Ray, Angiographic · Class II · 21 CFR 892.1600
OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-15 · 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
3.25
2019-02
0
3.88
2019-03
0
3.88
2019-04
0
8.54
2019-05
0
4.2
2019-06
0
2.56
2019-07
0
2.5
2019-08
0
1.86
2019-09
0
2.17
2019-10
0
2.8
2019-11
0
2
2019-12
0
3.45
2020-01
0
2.22
2020-02
0
3.22
2020-03
0
1.5
2020-04
0
1
2020-05
0
1.5
2020-06
0
3.33
2020-07
0
2.13
2020-08
0
1.91
2020-09
0
2.69
2020-10
0
2.56
2020-11
0
2.45
2020-12
0
2.25
2021-01
0
2.44
2021-02
0
2
2021-03
0
3.16
2021-04
0
5.06
2021-05
0
4.05
2021-06
0
4.82
2021-07
0
3.53
2021-08
0
3.67
2021-09
0
4.53
2021-10
0
2.59
2021-11
0
3.4
2021-12
0
4.85
2022-01
0
2.78
2022-02
0
4.17
2022-03
0
4.82
2022-04
0
4.75
2022-05
0
7.94
2022-06
0
8.08
2022-07
0
4.41
2022-08
0
4.05
2022-09
0
4.15
2022-10
0
17.71
2022-11
0
42.58
2022-12
0
51.06
2023-01
0
65.77
2023-02
0
47.15
2023-03
0
76.56
2023-04
0
51.64
2023-05
0
43
2023-06
0
35
2023-07
0
25.91
2023-08
0
34.95
2023-09
0
42.55
2023-10
0
42.28
2023-11
0
47.8
2023-12
0
50.24
2024-01
0
39.1
2024-02
0
70.82
2024-03
0
50.88
2024-04
0
35.65
2024-05
0
37.78
2024-06
0
52.92
2024-07
0
61
2024-08
0
47.06
2024-09
0
47.82
2024-10
0
50
2024-11
0
36.44
2024-12
0
39.47
2025-01
0
38.41
2025-02
0
53.39
2025-03
0
38.5
2025-04
0
59.69
2025-05
0
53.29
2025-06
0
67.41
2025-07
0
71.12
2025-08
0
96.19
2025-09
0
195.36
2025-10
0
147.4
2025-11
0
92
2025-12
0
19.48
2026-01
0
23.47
2026-02
0
14.19
2026-03
0
15.48
2026-04
0
13.16
2026-05
0
14
2026-06
0
13.67
This device (reports/month)Average device in IZI, OWN (reports/device/month)
Regulatory clearances
K133719 SESE 2014-03-27 (k number procode)
Predicate lineage
K133719 — cited as predicate by K162885, K243645
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — HAMAMATSU PHOTONICS K.K.