Philips IntelliSite Pathology Solution

GUDID 00884838085640

Philips Electronics Nederland B.V.

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

Devices Manufactured by Philips Electronics Nederland B.V.

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• 00884838098244 - INTELLISPACE™ COGNITION: 2019-11-07
• 00884838085640 - Philips IntelliSite Pathology Solution: 2019-04-23
• 00884838085640 - Philips IntelliSite Pathology Solution: 2019-04-23