Philips IntelliSite Pathology Solution 760001

GUDID 00884838092105

Philips Medical Systems Nederland B.V.

Microscope slide digital imaging scanner IVD

• Primary Device ID: 00884838092105
• NIH Device Record Key: 795117be-714c-4674-97cb-9025bec17173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips IntelliSite Pathology Solution
• Version Model Number: 5.1
• Catalog Number: 760001
• 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: 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	00884838092105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233204

FDA Product Code

• PSY: Whole Slide Imaging System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-23
• Device Publish Date: 2024-07-15

On-Brand Devices [Philips IntelliSite Pathology Solution]

• 00884838092105: 5.1
• 00884838121270: Whole Slide Imaging System. The device is an automated digital slide creation, viewing and manag