FDA 510(k)

Himaging Bronchscope System

Numéro K : K251894 · 2025-09-23

DemandeurHimaging Technology (Shanghai) Co., Ltd.

Date de décision2025-09-23

Code produitEOQ

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

Himaging Bronchscope System is the device name listed in this FDA 510(k) record. The listed applicant is Himaging Technology (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-23 under 510(k) number K251894. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Himaging Bronchscope System?

Himaging Bronchscope System is a medical device that received FDA 510(k) clearance on 2025-09-23. The listed applicant is Himaging Technology (Shanghai) Co., Ltd.. The 510(k) number is K251894.

When did Himaging Bronchscope System receive FDA 510(k) clearance?

Himaging Bronchscope System received FDA 510(k) clearance on 2025-09-23, under 510(k) number K251894.

Who is the listed applicant for Himaging Bronchscope System?

The FDA 510(k) record lists Himaging Technology (Shanghai) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Himaging Bronchscope System?

The FDA product code for Himaging Bronchscope System is EOQ.

Essais cliniques associés

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Dispositifs connexes (Code : EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Source officielle

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