DELTA4

Accelerator, Linear, Medical

SCANDIDOS AB

The following data is part of a premarket notification filed by Scandidos Ab with the FDA for Delta4.

Pre-market Notification Details

• Device ID: K052920
• 510k Number: K052920
• Device Name: DELTA4
• Classification: Accelerator, Linear, Medical
• Applicant: SCANDIDOS AB LEFFLERSGATAN 5 Uppsala, SE Se-754 50
• Contact: Thomas Matzen
• Correspondent: Thomas Matzen; SCANDIDOS AB LEFFLERSGATAN 5 Uppsala, SE Se-754 50
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-17
• Decision Date: 2006-01-12
• Summary: summary