FullFocusTM Whole Slide Image Viewer

GUDID 00860007599101

PAIGE.AI, INC.

Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system Pathology information system

• Primary Device ID: 00860007599101
• NIH Device Record Key: 5dd3343d-32c0-4ca8-abfb-eeda596791d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FullFocusTM Whole Slide Image Viewer
• Version Model Number: 2.X
• Company DUNS: 081368558
• Company Name: PAIGE.AI, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007599101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201005

FDA Product Code

• QKQ: Digital Pathology Image Viewing And Management Software

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: 2021-10-01
• Device Publish Date: 2021-09-23

Devices Manufactured by PAIGE.AI, INC.

• 00860007599118 - Paige Prostate: 2021-11-18 Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer
• 00860007599101 - FullFocusTM Whole Slide Image Viewer: 2021-10-01
• 00860007599101 - FullFocusTM Whole Slide Image Viewer: 2021-10-01