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FDA 510(k)

I4 (Integrated Intelligent Imaging Informatics) system

K-Number: K160315 · 2016-02-19

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2016-02-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I4 (Integrated Intelligent Imaging Informatics) system is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K160315. 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 I4 (Integrated Intelligent Imaging Informatics) system?

I4 (Integrated Intelligent Imaging Informatics) system is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K160315.

When did I4 (Integrated Intelligent Imaging Informatics) system receive FDA 510(k) clearance?

I4 (Integrated Intelligent Imaging Informatics) system received FDA 510(k) clearance on 2016-02-19, under 510(k) number K160315.

Who is the listed applicant for I4 (Integrated Intelligent Imaging Informatics) system?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I4 (Integrated Intelligent Imaging Informatics) system?

The FDA product code for I4 (Integrated Intelligent Imaging Informatics) system is LLZ.

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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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