VIRTUE

System, Image Processing, Radiological

DIAGNOSOFT, INC.

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

Pre-market Notification Details

• Device ID: K111833
• 510k Number: K111833
• Device Name: VIRTUE
• Classification: System, Image Processing, Radiological
• Applicant: DIAGNOSOFT, INC. 49 PLAIN STREET North Attleboro, MA 02760
• Contact: Jeffrey Roberts
• Correspondent: Jeffrey Roberts; DIAGNOSOFT, INC. 49 PLAIN STREET North Attleboro, MA 02760
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-28
• Decision Date: 2011-09-21
• Summary: summary