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FDA 510(k)

Image Navigator by Immuno Concepts

K-Number: K160265 · 2016-06-17

ApplicantImmuno Concepts, N.A. , Ltd.
Decision Date2016-06-17
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Image Navigator by Immuno Concepts is a medical device manufactured by Immuno Concepts, N.A. , Ltd.. It received FDA 510(k) clearance on 2016-06-17 under approval number K160265. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Image Navigator by Immuno Concepts?

Image Navigator by Immuno Concepts is a medical device that received FDA 510(k) clearance on 2016-06-17. It is manufactured by Immuno Concepts, N.A. , Ltd.. The 510(k) number is K160265.

When was Image Navigator by Immuno Concepts approved by the FDA?

Image Navigator by Immuno Concepts received FDA 510(k) clearance on 2016-06-17, under approval number K160265.

What company makes Image Navigator by Immuno Concepts?

Image Navigator by Immuno Concepts is manufactured by Immuno Concepts, N.A. , Ltd..

What is the FDA product code for Image Navigator by Immuno Concepts?

The FDA product code for Image Navigator by Immuno Concepts is DHN.

Related PubMed Literature

PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025)

Other Devices by Immuno Concepts, N.A. , Ltd.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts K203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

Related Devices (Code: DHN)

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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.

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