510(k) K193319
K193319 is an FDA 510(k) premarket notification submitted by Vasoptic Medical, Inc. for the device "XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System". The FDA issued a decision of Substantially Equivalent on Jun 1, 2020. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 2020
- Date Received
- Dec 2, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type
- 510(k)