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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 a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-02-19 under approval 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. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K160315.

When was I4 (Integrated Intelligent Imaging Informatics) system approved by the FDA?

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

What company makes I4 (Integrated Intelligent Imaging Informatics) system?

I4 (Integrated Intelligent Imaging Informatics) system is manufactured by Philips Medical Systems Nederland B.V..

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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Related PubMed Literature

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Other Devices by Philips Medical Systems Nederland B.V.

K162940MultiBand SENSE K162955Multi-Modality Tumor Tracking (MMTT) application K162859Allura Xper FD series and Allura Xper OR Table series K160455AneurysmFlow K160147CT TrueView K1618392D Quantitative Analysis

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Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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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