The following data is part of a premarket notification filed by Vasoptic Medical Inc. with the FDA for Xycam Ri, Xycam Ri System, Xycam Retinal Imaging System.
| Device ID | K193319 |
| 510k Number | K193319 |
| Device Name: | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Vasoptic Medical Inc. 1215 East Fort Avenue, Suite 304 Baltimore, MD 21230 |
| Contact | Abhishek Rege |
| Correspondent | Abhishek Rege Vasoptic Medical Inc. 1215 East Fort Avenue, Suite 304 Baltimore, MD 21230 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-06-01 |
| Summary: | summary |