AEGIS

System, Image Processing, Radiological

SENTINELLE MEDICAL, INC.

The following data is part of a premarket notification filed by Sentinelle Medical, Inc. with the FDA for Aegis.

Pre-market Notification Details

• Device ID: K070244
• 510k Number: K070244
• Device Name: AEGIS
• Classification: System, Image Processing, Radiological
• Applicant: SENTINELLE MEDICAL, INC. 3080 YONGE STREET SUITE 6020 Toronto, Ontario, CA M4n 3n1
• Contact: Stephen Leung
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2007-01-25
• Decision Date: 2007-02-09
• Summary: summary