qER-Quant

GUDID 00860005118137

The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images.

QURE.AI TECHNOLOGIES PRIVATE LIMITED

Radiology DICOM image processing application software

• Primary Device ID: 00860005118137
• NIH Device Record Key: 52aeba6c-5c3e-4371-8882-d09b5685f23e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: qER-Quant
• Version Model Number: 1.0.0
• Company DUNS: 860393884
• Company Name: QURE.AI TECHNOLOGIES PRIVATE LIMITED
• 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: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai
• Phone: +1(262)347-9734
• Email: support@qure.ai

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005118137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211222

FDA Product Code

• QIH: Automated Radiological Image Processing 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: 2022-06-08
• Device Publish Date: 2022-05-31

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