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FDA 510(k)

Longitudinal Brain Imaging (LoBI) application

K-Number: K163250 · 2017-05-11

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2017-05-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Longitudinal Brain Imaging (LoBI) application is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-05-11 under approval number K163250. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Longitudinal Brain Imaging (LoBI) application?

Longitudinal Brain Imaging (LoBI) application is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K163250.

When was Longitudinal Brain Imaging (LoBI) application approved by the FDA?

Longitudinal Brain Imaging (LoBI) application received FDA 510(k) clearance on 2017-05-11, under approval number K163250.

What company makes Longitudinal Brain Imaging (LoBI) application?

Longitudinal Brain Imaging (LoBI) application is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Longitudinal Brain Imaging (LoBI) application?

The FDA product code for Longitudinal Brain Imaging (LoBI) application is LLZ.

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Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41437380 Applications of artificial intelligence in non-small cell lung cancer: from precision diagnosis to personalized prognosis and therapy. Journal of translational medicine (2025)

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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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