K253217

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

510(k) number
K253217
Device name
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
Applicant
Medimaging Integrated Solution, Inc (Miis) TW
Product code
HRX — Arthroscope
Decision date
2025-12-23
Date received
2025-09-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K253217.pdf

Official FDA record: K253217
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.