MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)— 510(k) K253217

Substantially Equivalent

Medimaging Integrated Solution, Inc (Miis)

FDA 510(k) clearance K253217 for MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700), Substantially Equivalent on 2025-12-23. Applicant: Medimaging Integrated Solution, Inc (Miis).

Clearance details

Applicant: Medimaging Integrated Solution, Inc (Miis)
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2025-09-29
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.