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FDA 510(k)

Neocis Planning Software Application (NPSA) for 3rd Party PCs

K-Number: K191363 · 2019-10-02

ApplicantNeocis, Inc.
Decision Date2019-10-02
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Planning Software Application (NPSA) for 3rd Party PCs is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2019-10-02 under approval number K191363. 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 Planning Software Application (NPSA) for 3rd Party PCs?

Neocis Planning Software Application (NPSA) for 3rd Party PCs is a medical device that received FDA 510(k) clearance on 2019-10-02. It is manufactured by Neocis, Inc.. The 510(k) number is K191363.

When was Neocis Planning Software Application (NPSA) for 3rd Party PCs approved by the FDA?

Neocis Planning Software Application (NPSA) for 3rd Party PCs received FDA 510(k) clearance on 2019-10-02, under approval number K191363.

What company makes Neocis Planning Software Application (NPSA) for 3rd Party PCs?

Neocis Planning Software Application (NPSA) for 3rd Party PCs is manufactured by Neocis, Inc..

What is the FDA product code for Neocis Planning Software Application (NPSA) for 3rd Party PCs?

The FDA product code for Neocis Planning Software Application (NPSA) for 3rd Party PCs is PLV.

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Related PubMed Literature

PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025)

Other Devices by Neocis, Inc.

K161399Neocis Guidance System K182776Neocis Guidance System K173402Neocis Guidance System (NGS) with Chairside Splint 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)

K161399Neocis Guidance SystemNeocis, Inc. K161406NavidentClaronav, Inc. K182776Neocis Guidance SystemNeocis, Inc. K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, 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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