Concentriq AP-Dx 4.8.1

GUDID 00860006054595

Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.

Proscia Inc.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00860006054595
• NIH Device Record Key: d9173c19-b795-490d-84c2-118e2322e050
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concentriq AP-Dx
• Version Model Number: DX040US
• Catalog Number: 4.8.1
• Company DUNS: 079846027
• Company Name: Proscia 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: false
• 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	00860006054595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230839

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: 2025-05-16
• Device Publish Date: 2025-05-08

On-Brand Devices [Concentriq AP-Dx]

• 00860006054519: Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professi
• 00860006054595: Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology sl