Collage

System, Image Processing, Radiological

ANATOMAGE INC.

The following data is part of a premarket notification filed by Anatomage Inc. with the FDA for Collage.

Pre-market Notification Details

• Device ID: K150976
• 510k Number: K150976
• Device Name: Collage
• Classification: System, Image Processing, Radiological
• Applicant: ANATOMAGE INC. 111 N. MARKET STREET #500 San Jose, CA 95113
• Contact: Sean Xu
• Correspondent: Sean Xu; ANATOMAGE INC. 111 N. MARKET STREET #500 San Jose, CA 95113
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-13
• Decision Date: 2015-06-04
• Summary: summary