# K253217: MiiS Horus Arthroscope  (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

- Pathway: 510(k) (Traditional)
- Applicant: Medimaging Integrated Solution, Inc (Miis)
- Decided: Dec 23, 2025 after 85 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950862 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201134: Arthrex NanoScope System, Arthrex, Inc. (2020) Summary page 6.

## Indications for use
MiiS Horus Arthroscope: The MiiS Horus Arthroscope is a sterile and single-use device designed for operation with its compatible display system. It is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization of an interior cavity of the body through a surgical opening. The device is intended for use in a hospital or medical office environment and is designed for use in adults. MiiS Horus Endoscope Display System -Tablet: The MiiS Horus Endoscope Display System -Tablet is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation. MiiS Horus Endoscope Display System -Video Box: The MiiS Horus Endoscope Display System -Video Box is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.

Source page: https://510kreport.com/device/K253217
Methodology: https://510kreport.com/methodology