FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
K Number: K253217
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
7
Review Days
85
Basic Information
- Device Name
- MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
- K Number
- K253217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medimaging Integrated Solution, Inc (Miis)
- Date Received
- September 29, 2025
- Decision Date
- December 23, 2025
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Medimaging Integrated Solution, Inc (Miis)
| K Number | Device Name | ||
|---|---|---|---|
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | May 1, 2024 | Substantially Equivalent |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box | Oct 6, 2023 | Substantially Equivalent |
| K214050 | ENT Nasopharyngoscope and Accessories | Jul 1, 2022 | Substantially Equivalent |
| K193188 | MiiS Horus Eye Anterior Camera | Jan 14, 2020 | Substantially Equivalent |
| K181260 | MiiS Horus Scope DPT 100 | Jun 21, 2019 | Substantially Equivalent |
| K170470 | Digital Eye Anterior Camera | Oct 6, 2017 | Substantially Equivalent |