DynaCAD

System, Image Processing, Radiological

Invivo Corporation

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Dynacad.

Pre-market Notification Details

• Device ID: K192200
• 510k Number: K192200
• Device Name: DynaCAD
• Classification: System, Image Processing, Radiological
• Applicant: Invivo Corporation 3545 SW 47th Ave. Gainesville, FL 32608
• Contact: Kym Rupp
• Correspondent: Prithul Bom; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2019-08-13
• Decision Date: 2019-10-09
• Summary: summary