QuantX

Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

Quantitative Insights, Inc

The following data is part of a De Novo classification by Quantitative Insights, Inc with the FDA for Quantx.

Pre-market Notification Details

• DeNovo ID: DEN170022
• Device Name: QuantX
• Classification: Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
• Applicant: Quantitative Insights, Inc 1452 E 53rd St Chicago, IL 60615
• Contact: Robert Tomek
• Product Code: POK
• CFR Regulation Number: 892.2060 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Radiology
• Classification Advisory: Radiology
• Type: Direct
• Date Received: 2017-04-07
• Decision Date: 2017-07-19
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B80711	DEN170022	000