Medical Device Manufacturer · TW , Hsinchu

Medimaging Integrated Solution, Inc (Miis)

7 submissions · 7 cleared · Since 2017
7
Total
7
Cleared
0
Denied

Medimaging Integrated Solution, Inc (Miis) — FDA 510(k) Submissions

Medimaging Integrated Solution, Inc (Miis) has submitted 7 FDA 510(k) premarket notifications since 2017, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Biomicroscope, Slit-lamp, Ac-powered, Bronchoscope (flexible Or Rigid), Arthroscope, Tonometer, Ac-powered, Nasopharyngoscope (flexible Or Rigid) . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
K253217 · HRX Arthroscope · Orthopedic
Dec 2025 85d
MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
K234113 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
May 2024 126d
VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
K223926 · FAJ Cystoscope And... · Gastroenterology & Urology
Oct 2023 280d
ENT Nasopharyngoscope and Accessories
K214050 · EOB Nasopharyngoscope... · Ear, Nose, Throat
Jul 2022 186d
MiiS Horus Eye Anterior Camera
K193188 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Jan 2020 57d
MiiS Horus Scope DPT 100
K181260 · HKX Tonometer, Ac-powered · Ophthalmic
Jun 2019 406d
Digital Eye Anterior Camera
K170470 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Oct 2017 232d
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All7 Ophthalmic 3 Ear, Nose, Throat 2 Gastroenterology & Urology 1 Orthopedic 1