MULTIVIEW

System, Image Processing, Radiological

HOLOGIC, INC.

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

Pre-market Notification Details

• Device ID: K132316
• 510k Number: K132316
• Device Name: MULTIVIEW
• Classification: System, Image Processing, Radiological
• Applicant: HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730
• Contact: Eileen M Boyle
• Correspondent: Eileen M Boyle; HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-25
• Decision Date: 2013-10-30