# K234113: MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

- Pathway: 510(k) (Traditional)
- Applicant: Medimaging Integrated Solution, Inc (Miis)
- Decided: May 1, 2024 after 126 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921244 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor, Ambu A/S (2018) Summary page 6.

## Indications for use
MiiS Horus Bronchoscope: The MiiS Horus Bronchoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700). The device provides endoscopic visualization of airways and tracheobronchial tree, in conjunction with displaying system to perform various endoscopic procedures. The MiiS Horus Bronchoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults. MiiS Horus Endoscope Display System -Tablet: The MiiS Horus Endoscope Display System -Tablet (EDS 500) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation. MiiS Horus Endoscope Display System -Video Box: The MiiS Horus Endoscope Display System -Video Box (EVS 700) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.

Source page: https://510kreport.com/device/K234113
Methodology: https://510kreport.com/methodology