Himaging Bronchscope System— 510(k) K251894

Name: FDA 510(k) clearance K251894
Creator: U.S. Food and Drug Administration
Published: 2025-09-23

Substantially Equivalent

Himaging Technology (Shanghai) Co., Ltd.

FDA 510(k) clearance K251894 for Himaging Bronchscope System, Substantially Equivalent on 2025-09-23. Applicant: Himaging Technology (Shanghai) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Himaging Technology (Shanghai) Co., Ltd.
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2025-06-20
Decision date: 2025-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EOQ

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K260382 — MONARCH Platform (MON-000008)2026-07-25
K254037 — LungFlow Airway Catheter2026-07-10
K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16
K260565 — SmartClip Delivery Catheter (ADR-1715)2026-05-14
K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)2026-04-23

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.