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FDA 510(k)

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

K-Number: K193319 · 2020-06-01

ApplicantVasoptic Medical, Inc.
Decision Date2020-06-01
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Vasoptic Medical, Inc.. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K193319. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System?

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Vasoptic Medical, Inc.. The 510(k) number is K193319.

When did XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System receive FDA 510(k) clearance?

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System received FDA 510(k) clearance on 2020-06-01, under 510(k) number K193319.

Who is the listed applicant for XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System?

The FDA 510(k) record lists Vasoptic Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System?

The FDA product code for XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is HKI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05726058Ocular Blood Flow Imaging for Glaucoma AssessmentRECRUITINGNCT07641738Collecting Data on Retinal Blood Blood Flow and Blood Vessel Shape/Appearance Using an Investigational Device, XyCAM CRE, and to Then Compare Those Images With Images Collected From a Patient's Routine Clinical Examination.NOT_YET_RECRUITING

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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