MiiS Horus Eye Anterior Camera
FDA 510(k) K193188 · Medimaging Integrated Solution, Inc (Miis)
510(k) numberK193188
Submission
- Device name
- MiiS Horus Eye Anterior Camera
- Applicant
- Medimaging Integrated Solution, Inc (Miis)
Hsinchu, CN - Received
- November 18, 2019
- Decision date
- January 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
Other 510(k)s with product code HJO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253834 | Visuref 600HJO · Traditional | Carl Zeiss Vision GmbH | 03/18/2026SE |
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | Cylite Pty. , Ltd. | 03/08/2024SE |
| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
| K182306 | Sunkingdom Slit LampHJO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 11/22/2018SE |
| K173771 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 08/24/2018SE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
| K163564 | Slit Lamp SL-2000HJO · Traditional | Nidek Co., Ltd. | 05/19/2017SE |
More from Nidek Co., Ltd.
| 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 |
| K181260 | MiiS Horus Scope DPT 100HKX · Traditional | 06/21/2019SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | 10/06/2017SE |
Questions and answers
When was MiiS Horus Eye Anterior Camera cleared by the FDA?
MiiS Horus Eye Anterior Camera (K193188) received a 510(k) decision of Substantially Equivalent on January 14, 2020, 57 days after the submission was received.
What is the product code of K193188?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.