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FDA 510(k)

Huvitz Imaging System

K-Number: K161829 · 2017-04-06

ApplicantHuvitz Co., Ltd.
Decision Date2017-04-06
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Huvitz Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K161829. 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 2017-04-06. The listed applicant is Huvitz Co., Ltd.. The 510(k) number is K161829.

When did Huvitz Imaging System receive FDA 510(k) clearance?

Huvitz Imaging System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K161829.

Who is the listed applicant for Huvitz Imaging System?

The FDA 510(k) record lists Huvitz Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Huvitz Imaging System?

The FDA product code for Huvitz Imaging System is NFJ.

Other records listing Huvitz Co., Ltd. as applicant

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.

K232143Applanation Tonometer HT-5000K202097Fundus CameraK191615Huvitz Imaging System

Related Devices (Code: NFJ)

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.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon Healthcare Solutions

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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