Concentriq AP-Dx-US US

GUDID 00860006054557

Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

Proscia Inc.

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00860006054557
• NIH Device Record Key: 684a098f-c87c-4f6f-aa9c-c90dbb0e79b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concentriq AP-Dx-US
• Version Model Number: 4.6
• 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: true
• 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: info@proscia.com
• Phone: +1 (215) 608-5411
• Email: info@proscia.com
• Phone: +1 (215) 608-5411
• Email: info@proscia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006054557 [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: 2025-01-23
• Device Publish Date: 2025-01-15

Devices Manufactured by Proscia Inc.

• 00860006054557 - Concentriq AP-Dx-US: 2025-01-23Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
• 00860006054557 - Concentriq AP-Dx-US: 2025-01-23 Concentriq® AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology
• 00860006054519 - Concentriq AP-Dx: 2024-09-03 Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation