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FDA 510(k), K193319, XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
FDA 510(k), K193319, XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
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510(K) Number: K193319
Device Name: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Manufacturer: Vasoptic Medical Inc.
Device Classification Name: Camera, Ophthalmic, Ac-Powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 12/02/2019
Decision Date: 06/01/2020
Regulation Medical Specialty: Ophthalmic
Device Name: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
Manufacturer: Vasoptic Medical Inc.
Device Classification Name: Camera, Ophthalmic, Ac-Powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 12/02/2019
Decision Date: 06/01/2020
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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