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: K142037
• 510k Number: K142037
• Device Name: QUANTRA
• Classification: System, Image Processing, Radiological
• Applicant: HOLOGIC, INC. 2585 AUGUSTINE DR Santa Clara, CA 95054
• Contact: Catherine Williams
• Correspondent: Catherine Williams; HOLOGIC, INC. 2585 AUGUSTINE DR Santa Clara, CA 95054
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-28
• Decision Date: 2014-10-10
• Summary: summary