Philips IntelliSite Pathology Solution

GUDID 00884838085640

Philips Electronics Nederland B.V.

Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD Microscope slide digital imaging scanner IVD

• Primary Device ID: 00884838085640
• NIH Device Record Key: 0f75b695-baa4-4b33-ad6d-81c835398855
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips IntelliSite Pathology Solution
• Version Model Number: 3.x
• Company DUNS: 492079296
• Company Name: Philips Electronics Nederland B.V.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838085640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172174

FDA Product Code

• PSY: Whole slide imaging system

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-12-15

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