QER-Quant

Automated Radiological Image Processing Software

Qure.ai Technologies

The following data is part of a premarket notification filed by Qure.ai Technologies with the FDA for Qer-quant.

Pre-market Notification Details

• Device ID: K211222
• 510k Number: K211222
• Device Name: QER-Quant
• Classification: Automated Radiological Image Processing Software
• Applicant: Qure.ai Technologies Level 7, Commerz II, International Business Park, Oberoi Garden City, Goregaon(E) Mumbai, IN 400063
• Contact: Pooja Rao
• Correspondent: Pooja Rao; Qure.ai Level 7, Commerz II, International Business Park, Oberoi Garden City, Goregaon(E) Mumbai, IN 400063
• Product Code: QIH
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-23
• Decision Date: 2021-07-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860005118137	K211222	000