Submission Details
| 510(k) Number | K170470 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 16, 2017 |
| Decision Date | October 06, 2017 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Digital Eye Anterior Camera
Oct 2017
Decision
232d
Days
Class 2
Risk
About This 510(k) Submission
K170470 is an FDA 510(k) clearance for the Digital Eye Anterior Camera, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Medimaging Integrated Solution, Inc (Miis) (Hsinchu, TW). The FDA issued a Cleared decision on October 6, 2017, 232 days after receiving the submission on February 16, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.
Device Classification
| Product Code | HJO — Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.1850 |
Manufacturer
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