Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Vasoptic Medical, Inc.. It received FDA 510(k) clearance on 2020-06-01 under approval 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. It is manufactured by Vasoptic Medical, Inc.. The 510(k) number is K193319.

When was XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System approved by the FDA?

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

What company makes XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System?

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System is manufactured by Vasoptic Medical, Inc..

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Related Devices (Code: HKI)

K161727Eyenez Ophthalmic CameraEyenez, LLC K152729MICROPERIMETER MP-3Nidek Co., Ltd. K153239LSFG-NAVISoftcare Co., Ltd. K152869LipiView II Ocular Surface InterferometerTearscience, Inc. K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical K163021HAAG-STREIT FUNDUS MODULE 300Optomed OY

Official Source

View on FDA Database →

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

↑