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FDA 510(k)

Huvitz Imaging System

K-Number: K191615 · 2019-07-18

ApplicantHuvitz Co., Ltd.
Decision Date2019-07-18
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Huvitz Imaging System is a medical device manufactured by Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2019-07-18 under approval number K191615. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Huvitz Imaging System?

Huvitz Imaging System is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Huvitz Co., Ltd.. The 510(k) number is K191615.

When was Huvitz Imaging System approved by the FDA?

Huvitz Imaging System received FDA 510(k) clearance on 2019-07-18, under approval number K191615.

What company makes Huvitz Imaging System?

Huvitz Imaging System is manufactured by Huvitz Co., Ltd..

What is the FDA product code for Huvitz Imaging System?

The FDA product code for Huvitz Imaging System is NFJ.

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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: 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)

Other Devices by Huvitz Co., Ltd.

K161829Huvitz Imaging System K202097Fundus Camera K232143Applanation Tonometer HT-5000

Related Devices (Code: NFJ)

K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation K170638Retina WorkplaceCarl Zeiss Meditec, AG K171098AXIS Image Management SystemSonomed, Inc. K161829Huvitz Imaging SystemHuvitz Co., Ltd. K162039OptosAdvance 4.0 SoftwareOptos Plc. K181501AfinaNeurovision Imaging, LLC

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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