Paige Prostate

GUDID 00860007599118

Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.

PAIGE.AI, INC.

Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD Histology/cytology/microbiology image-analysis interpretive software IVD

• Primary Device ID: 00860007599118
• NIH Device Record Key: 50574731-36b3-45e1-bd64-5204f3bef0bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paige Prostate
• Version Model Number: 1.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	00860007599118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200080

FDA Product Code

• QPN: Software Algorithm Device To Assist Users In Digital Pathology

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: 2021-11-18
• Device Publish Date: 2021-11-10

Devices Manufactured by PAIGE.AI, INC.

• 00860007599118 - Paige Prostate: 2021-11-18Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
• 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