QuantX 1

GUDID B80711

QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.

QLARITY IMAGING, LLC

Radiology PACS software

• Primary Device ID: B80711
• NIH Device Record Key: cb5dab50-6799-44b6-98e8-e03607be625e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantX
• Version Model Number: Breast MRI
• Catalog Number: 1
• Company DUNS: 108968505
• Company Name: QLARITY IMAGING, LLC
• 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

Customer Support Contacts

• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com
• Phone: 312-847-1627
• Email: mjohnston@qlarityimaging.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B80711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170022

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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: 2020-02-27
• Device Publish Date: 2020-02-19

On-Brand Devices [QuantX]

• B80731: QuantX is a software program that is used to view and analyze patient breast images.
• B80711: QuantX is a software program that analyzes patient breast images, and is designed to aid radiolo
• B80721: The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the