ALIGNRT

Accelerator, Linear, Medical

VISION RT LIMITED

The following data is part of a premarket notification filed by Vision Rt Limited with the FDA for Alignrt.

Pre-market Notification Details

• Device ID: K052682
• 510k Number: K052682
• Device Name: ALIGNRT
• Classification: Accelerator, Linear, Medical
• Applicant: VISION RT LIMITED DAWS HOUSE,33-35 DAWS LANE London, GB Nw7 4sd
• Contact: Norman Smith
• Correspondent: Daniel W Lehtonen; INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2005-09-28
• Decision Date: 2006-01-06
• Summary: summary