MiiS Horus Scope DPT 100
FDA 510(k) K181260 · Medimaging Integrated Solution, Inc (Miis)
510(k) numberK181260
Submission
- Device name
- MiiS Horus Scope DPT 100
- Applicant
- Medimaging Integrated Solution, Inc (Miis)
Hsinchu, CN - Received
- May 11, 2018
- Decision date
- June 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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More from Keeler Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | 12/23/2025SE |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus…EOQ · Traditional | 05/01/2024SE |
| K223926 | VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxFAJ · Traditional | 10/06/2023SE |
| K214050 | ENT Nasopharyngoscope and AccessoriesEOB · Traditional | 07/01/2022SE |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | 01/14/2020SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | 10/06/2017SE |
Questions and answers
When was MiiS Horus Scope DPT 100 cleared by the FDA?
MiiS Horus Scope DPT 100 (K181260) received a 510(k) decision of Substantially Equivalent on June 21, 2019, 406 days after the submission was received.
What is the product code of K181260?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.