QuantX

System, Image Processing, Radiological

Quantitative Insights, Inc.

The following data is part of a premarket notification filed by Quantitative Insights, Inc. with the FDA for Quantx.

Pre-market Notification Details

• Device ID: K170195
• 510k Number: K170195
• Device Name: QuantX
• Classification: System, Image Processing, Radiological
• Applicant: Quantitative Insights, Inc. 1452 E 53rd St. Chicago, IL 60615
• Contact: Robert Tomek
• Correspondent: Robert Tomek; Quantitative Insights, Inc. 1452 E 53rd St. Chicago, IL 60615
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-23
• Decision Date: 2017-05-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B80731	K170195	000