# Medimaging Integrated Solution, Inc (Miis)

- Location (FDA's records): Hsinchu, TW
- FDA decisions: 7 (2017–2025): 7 510(k) clearances
- Product codes: HJO (2), HKX (1), HRX (1), FAJ (1), EOB (1), EOQ (1)
- 510(k) review time since 2016: median 209 days, against 193 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ambu A/S: 3 (https://510kreport.com/company/ambu-a-s)
- Leica Microsystems, Inc. O.I.D.: 1 (https://510kreport.com/company/leica-microsystems-oid)
- Topcon Instrument Corporation of America: 1 (https://510kreport.com/company/topcon-instrument-of-america)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Kowa Co., Ltd.: 1 (https://510kreport.com/company/kowa)
- Medimaging Integrated Solutions, Inc. (Miis): 1 (https://510kreport.com/company/medimaging-integrated-solutions-miis)

## Firms that cite its devices most
- Medimaging Integrated Solution, Inc.: 1 (https://510kreport.com/company/medimaging-integrated-solution)

## Its most-cited devices
- K181260: MiiS Horus Scope DPT 100 (2019), cited by 1
- K170470: Digital Eye Anterior Camera (2017), cited by 1

## Recent decisions
- K253217: MiiS Horus Arthroscope  (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) (Dec 23, 2025)
- K234113: MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box (May 1, 2024)
- K223926: VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box (Oct 6, 2023)
- K214050: ENT Nasopharyngoscope and Accessories (Jul 1, 2022)
- K193188: MiiS Horus Eye Anterior Camera (Jan 14, 2020)
- K181260: MiiS Horus Scope DPT 100 (Jun 21, 2019)
- K170470: Digital Eye Anterior Camera (Oct 6, 2017)

Source page: https://510kreport.com/company/medimaging-integrated-solution-miis