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FDA 510(k)

Advanced Diffusion Analysis (ADA) application

K-Number: K173467 · 2017-12-12

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2017-12-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Advanced Diffusion Analysis (ADA) application is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-12-12 under approval number K173467. 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 Advanced Diffusion Analysis (ADA) application?

Advanced Diffusion Analysis (ADA) application is a medical device that received FDA 510(k) clearance on 2017-12-12. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K173467.

When was Advanced Diffusion Analysis (ADA) application approved by the FDA?

Advanced Diffusion Analysis (ADA) application received FDA 510(k) clearance on 2017-12-12, under approval number K173467.

What company makes Advanced Diffusion Analysis (ADA) application?

Advanced Diffusion Analysis (ADA) application is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Advanced Diffusion Analysis (ADA) application?

The FDA product code for Advanced Diffusion Analysis (ADA) application is LLZ.

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Related PubMed Literature

PMID: 33890129 [Diagnostics of diseases of the optic nerve head in times of artificial intelligence and big data]. Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft (2021) PMID: 32128936 Medical device active surveillance of spontaneous reports: A literature review of signal detection methods. Pharmacoepidemiology and drug safety (2020) PMID: 25644202 Regulatory frameworks for mobile medical applications. Expert review of medical devices (2015)

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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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