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 Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological 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