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FDA 510(k)

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

K-Number: K234113 · 2024-05-01

ApplicantMedimaging Integrated Solution, Inc (Miis)
Decision Date2024-05-01
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box is a medical device manufactured by Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2024-05-01 under approval number K234113. 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 MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box?

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K234113.

When was MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box approved by the FDA?

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box received FDA 510(k) clearance on 2024-05-01, under approval number K234113.

What company makes MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box?

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box is manufactured by Medimaging Integrated Solution, Inc (Miis).

What is the FDA product code for MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box?

The FDA product code for MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box is EOQ.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Medimaging Integrated Solution, Inc (Miis)

K170470Digital Eye Anterior Camera K181260MiiS Horus Scope DPT 100 K193188MiiS Horus Eye Anterior Camera K214050ENT Nasopharyngoscope and Accessories K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

View all 7 devices →

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.

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