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FDA 510(k)

Neocis Guidance System (NGS) with Yomi Plan v2.0.1

K-Number: K210711 · 2021-12-22

ApplicantNeocis, Inc.
Decision Date2021-12-22
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K210711. 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 (NGS) with Yomi Plan v2.0.1?

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Neocis, Inc.. The 510(k) number is K210711.

When was Neocis Guidance System (NGS) with Yomi Plan v2.0.1 approved by the FDA?

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 received FDA 510(k) clearance on 2021-12-22, under approval number K210711.

What company makes Neocis Guidance System (NGS) with Yomi Plan v2.0.1?

Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is manufactured by Neocis, Inc..

What is the FDA product code for Neocis Guidance System (NGS) with Yomi Plan v2.0.1?

The FDA product code for Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is PLV.

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Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37306642 Regulatory Framework for Implantable Neurostimulation Devices: Comparison of Systems in the US and European Union. Neuromodulation : journal of the International Neuromodulation Society (2024) PMID: 29659675 Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests. American journal of clinical pathology (2018)

Other Devices by Neocis, Inc.

K161399Neocis Guidance System 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)

View all 18 devices →

Related Devices (Code: PLV)

K161399Neocis Guidance SystemNeocis, Inc. 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.

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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