FullFocusTM Whole Slide Image Viewer

GUDID 00860007599101

PAIGE.AI, INC.

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