ASTRA

System, Image Processing, Radiological

CANDELIS, INC.

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

Pre-market Notification Details

• Device ID: K111694
• 510k Number: K111694
• Device Name: ASTRA
• Classification: System, Image Processing, Radiological
• Applicant: CANDELIS, INC. 18821 BARDEEN AVE. Irvine, CA 92612
• Contact: Vincent Cipolla
• Correspondent: Vincent Cipolla; CANDELIS, INC. 18821 BARDEEN AVE. Irvine, CA 92612
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-16
• Decision Date: 2011-09-15
• Summary: summary