510(k) K253217 ยท HRX Arthroscope
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), Hsinchu, TW |
| Decision | Substantially Equivalent, Dec 23, 2025 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253217
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.