Quantra

System, Image Processing, Radiological

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Quantra.

Pre-market Notification Details

• Device ID: K163623
• 510k Number: K163623
• Device Name: Quantra
• Classification: System, Image Processing, Radiological
• Applicant: HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810
• Contact: Neil Kelly
• Correspondent: Neil Kelly; HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-22
• Decision Date: 2017-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15420045510319	K163623	000