Digital Eye Anterior Camera
FDA 510(k) K170470 · Medimaging Integrated Solution, Inc (Miis)
510(k) numberK170470
Submission
- Device name
- Digital Eye Anterior Camera
- Applicant
- Medimaging Integrated Solution, Inc (Miis)
Hsinchu, TW - Received
- February 16, 2017
- Decision date
- October 6, 2017
- 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
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|---|---|---|---|
| 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 |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 01/14/2020SE |
| 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 |
| 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 |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | 01/14/2020SE |
| K181260 | MiiS Horus Scope DPT 100HKX · Traditional | 06/21/2019SE |
Questions and answers
When was Digital Eye Anterior Camera cleared by the FDA?
Digital Eye Anterior Camera (K170470) received a 510(k) decision of Substantially Equivalent on October 6, 2017, 232 days after the submission was received.
What is the product code of K170470?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.