Open Field Fluorescence Imaging Head
Model OPTO-CHD3100E · Guangdong Optomedic Technologies, Inc. · DI 06973031299986
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
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 2026-09-06 · 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 | 2.5 |
| 2019-02 | 0 | 3.56 |
| 2019-03 | 0 | 3.02 |
| 2019-04 | 0 | 3.86 |
| 2019-05 | 0 | 2.55 |
| 2019-06 | 0 | 3.48 |
| 2019-07 | 0 | 2.43 |
| 2019-08 | 0 | 2.43 |
| 2019-09 | 0 | 2.45 |
| 2019-10 | 0 | 2.72 |
| 2019-11 | 0 | 2.11 |
| 2019-12 | 0 | 2.46 |
| 2020-01 | 0 | 2.52 |
| 2020-02 | 0 | 2.75 |
| 2020-03 | 0 | 2.25 |
| 2020-04 | 0 | 2.52 |
| 2020-05 | 0 | 1.96 |
| 2020-06 | 0 | 2.83 |
| 2020-07 | 0 | 2.7 |
| 2020-08 | 0 | 4.08 |
| 2020-09 | 0 | 4.21 |
| 2020-10 | 0 | 3.81 |
| 2020-11 | 0 | 4.09 |
| 2020-12 | 0 | 3.64 |
| 2021-01 | 0 | 3.77 |
| 2021-02 | 0 | 3.59 |
| 2021-03 | 0 | 4.58 |
| 2021-04 | 0 | 4.75 |
| 2021-05 | 0 | 4.05 |
| 2021-06 | 0 | 4.37 |
| 2021-07 | 0 | 3.83 |
| 2021-08 | 0 | 3.83 |
| 2021-09 | 0 | 4.01 |
| 2021-10 | 0 | 3.79 |
| 2021-11 | 0 | 3.48 |
| 2021-12 | 0 | 4.52 |
| 2022-01 | 0 | 4.32 |
| 2022-02 | 0 | 4.91 |
| 2022-03 | 0 | 5.36 |
| 2022-04 | 0 | 6.25 |
| 2022-05 | 0 | 5.81 |
| 2022-06 | 0 | 6.28 |
| 2022-07 | 0 | 6.05 |
| 2022-08 | 0 | 5.99 |
| 2022-09 | 0 | 5.31 |
| 2022-10 | 0 | 7.07 |
| 2022-11 | 0 | 11.06 |
| 2022-12 | 0 | 10.97 |
| 2023-01 | 0 | 11.26 |
| 2023-02 | 0 | 8.51 |
| 2023-03 | 0 | 14.29 |
| 2023-04 | 0 | 9.51 |
| 2023-05 | 0 | 11.04 |
| 2023-06 | 0 | 11.06 |
| 2023-07 | 0 | 9.15 |
| 2023-08 | 0 | 9.56 |
| 2023-09 | 0 | 10.77 |
| 2023-10 | 0 | 10.4 |
| 2023-11 | 0 | 10.65 |
| 2023-12 | 0 | 10.58 |
| 2024-01 | 0 | 10.23 |
| 2024-02 | 0 | 13.46 |
| 2024-03 | 0 | 10.2 |
| 2024-04 | 0 | 10.1 |
| 2024-05 | 0 | 8.56 |
| 2024-06 | 0 | 10.94 |
| 2024-07 | 0 | 10.26 |
| 2024-08 | 0 | 11.29 |
| 2024-09 | 0 | 10.86 |
| 2024-10 | 0 | 11.7 |
| 2024-11 | 0 | 8.33 |
| 2024-12 | 0 | 8.71 |
| 2025-01 | 0 | 8.01 |
| 2025-02 | 0 | 10.66 |
| 2025-03 | 0 | 9.04 |
| 2025-04 | 0 | 10.87 |
| 2025-05 | 0 | 10.02 |
| 2025-06 | 0 | 11.7 |
| 2025-07 | 0 | 11.7 |
| 2025-08 | 0 | 19.06 |
| 2025-09 | 0 | 24.27 |
| 2025-10 | 0 | 25.75 |
| 2025-11 | 0 | 18.44 |
| 2025-12 | 0 | 8.06 |
| 2026-01 | 0 | 7.23 |
| 2026-02 | 0 | 6.54 |
| 2026-03 | 0 | 7.16 |
| 2026-04 | 0 | 7.44 |
| 2026-05 | 0 | 7.19 |
| 2026-06 | 0 | 6.56 |
Regulatory clearances
- K230407 SESE 2023-07-17 (k number procode)
Predicate lineage
K230407 — cites (transitively): K200737 (d1), K182606 (d2), K192174 (d2), K150956 (d3), K161792 (d3), K162885 (d3), K182907 (d3), K190729 (d3), K091515 (d4), K141077 (d4), K142310 (d4), K063345 (d4), K100371 (d4), K132475 (d4), K133719 (d4), K071619 (d4), K073088 (d4), K073130 (d4), K124031 (d5), K132785 (d5), K910132 (d5), K983566 (d6)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Guangdong Optomedic Technologies, Inc.
Nothing in the loaded window.