Himaging Bronchscope System
K-Number: K251894 · 2025-09-23
Decision Date2025-09-23
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Himaging Bronchscope System is a medical device manufactured by Himaging Technology (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-23 under approval number K251894. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Himaging Bronchscope System?
Himaging Bronchscope System is a medical device that received FDA 510(k) clearance on 2025-09-23. It is manufactured by Himaging Technology (Shanghai) Co., Ltd.. The 510(k) number is K251894.
When was Himaging Bronchscope System approved by the FDA?
Himaging Bronchscope System received FDA 510(k) clearance on 2025-09-23, under approval number K251894.
What company makes Himaging Bronchscope System?
Himaging Bronchscope System is manufactured by Himaging Technology (Shanghai) Co., Ltd..
What is the FDA product code for Himaging Bronchscope System?
The FDA product code for Himaging Bronchscope System is EOQ.
Related Devices (Code: EOQ)
K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView MonitorAmbu A/S
K152319Auris Robotic Endoscopy System (ARES)Auris Surgical Robotics, Inc.
K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)Prosurg, Inc.
K171492B7 2C Occlusion BalloonSpiration, Inc.
K163537Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC
K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.