AISight Dx

GUDID 00860006696221

PathAI, Inc.

Histology/cytology/microbiology image-analysis interpretive software IVD

• Primary Device ID: 00860006696221
• NIH Device Record Key: 8fd8ca8e-f045-4cc7-bbd7-89cbb59693d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AISight Dx
• Version Model Number: 11124001
• Company DUNS: 080255082
• Company Name: PathAI, 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: true
• Serial Number: false
• 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	00860006696221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243391

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: 2025-07-16
• Device Publish Date: 2025-07-08