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)

NFC-600 Automated Portable Retinal Camera

K-Number: K210197 · 2021-04-13

ApplicantCrystalvue Medical Corporation
Decision Date2021-04-13
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NFC-600 Automated Portable Retinal Camera is a medical device manufactured by Crystalvue Medical Corporation. It received FDA 510(k) clearance on 2021-04-13 under approval number K210197. 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 NFC-600 Automated Portable Retinal Camera?

NFC-600 Automated Portable Retinal Camera is a medical device that received FDA 510(k) clearance on 2021-04-13. It is manufactured by Crystalvue Medical Corporation. The 510(k) number is K210197.

When was NFC-600 Automated Portable Retinal Camera approved by the FDA?

NFC-600 Automated Portable Retinal Camera received FDA 510(k) clearance on 2021-04-13, under approval number K210197.

What company makes NFC-600 Automated Portable Retinal Camera?

NFC-600 Automated Portable Retinal Camera is manufactured by Crystalvue Medical Corporation.

What is the FDA product code for NFC-600 Automated Portable Retinal Camera?

The FDA product code for NFC-600 Automated Portable Retinal Camera is HKI.

Related Clinical Trials

NCT06105892 Eye Recovery Automation for Post Injury Dysfunction (iRAPID) RECRUITING NCT07495345 Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001) COMPLETED

Other Devices by Crystalvue Medical Corporation

K180820Tono Vue Non-Contact Tonometer K182199NFC-700 non-mydriatic auto fundus camera

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.

↑