MiiS Horus Arthroscope (EJA 100) +2 more— 510(k) K253217
Substantially EquivalentMedimaging Integrated Solution, Inc (Miis)
FDA 510(k) clearance K253217 for MiiS Horus Arthroscope (EJA 100) +2 more, Substantially Equivalent on 2025-12-23. Applicant: Medimaging Integrated Solution, Inc (Miis). Device class: 2.
Clearance details
- Device name as filed
- 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)
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu, TW
Recent devices under product code HRX
view allMore clearances from Medimaging Integrated Solution, Inc (Miis)
view all- K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
- K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
- K214050 — ENT Nasopharyngoscope and Accessories
- K193188 — MiiS Horus Eye Anterior Camera
- K181260 — MiiS Horus Scope DPT 100
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . 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.