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FDA 510(k)

Neocis Guidance System

K-Number: K161399 · 2016-12-22

ApplicantNeocis, Inc.
Decision Date2016-12-22
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2016-12-22 under approval number K161399. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neocis Guidance System?

Neocis Guidance System is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Neocis, Inc.. The 510(k) number is K161399.

When was Neocis Guidance System approved by the FDA?

Neocis Guidance System received FDA 510(k) clearance on 2016-12-22, under approval number K161399.

What company makes Neocis Guidance System?

Neocis Guidance System is manufactured by Neocis, Inc..

What is the FDA product code for Neocis Guidance System?

The FDA product code for Neocis Guidance System is PLV.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) 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: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

Other Devices by Neocis, Inc.

K182776Neocis Guidance System K173402Neocis Guidance System (NGS) with Chairside Splint K191363Neocis Planning Software Application (NPSA) for 3rd Party PCs K191605Neocis Guidance System (NGS) K203401Neocis Guidance System (NGS) with Patient Splints (EPS) K202264Neocis Guidance System (NGS) with Yomi Plan v2.0

View all 18 devices →

Related Devices (Code: PLV)

K161406NavidentClaronav, Inc. K182776Neocis Guidance SystemNeocis, Inc. K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc. K191605Neocis Guidance System (NGS)Neocis, Inc. K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc.

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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