I4 (Integrated Intelligent Imaging Informatics)

GUDID 00884838074743

I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. I4 (Integrated Intelligent Imaging Informatics) is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838074743
• NIH Device Record Key: 7175eb46-15e3-4362-8ccc-91a048139d00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I4 (Integrated Intelligent Imaging Informatics)
• Version Model Number: 1.x
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com
• Phone: +1(800)722-9377
• Email: healthcare@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838074743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160315

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• 00884838119321 - Philips Sentinelle: 2024-12-25 dS 3.0T 4CH Lateral Left
• 00884838119338 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Right