Concentriq AP-Dx US

GUDID 00860006054519

Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

Proscia Inc.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00860006054519
• NIH Device Record Key: 7fb8b4cc-bb37-4a72-a7f2-33708840f02b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concentriq AP-Dx
• Version Model Number: 4.5
• Catalog Number: US
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com
• Phone: +1 215 608 5411
• Email: support@proscia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006054519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230839

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: 2024-09-03
• Device Publish Date: 2024-08-26