AGILITY

Accelerator, Linear, Medical

ELEKTA LTD.

The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Agility.

Pre-market Notification Details

• Device ID: K121328
• 510k Number: K121328
• Device Name: AGILITY
• Classification: Accelerator, Linear, Medical
• Applicant: ELEKTA LTD. FLEMING WAY LINAC HOUSE Crawley, West Sussex, GB Rh10 9rr
• Contact: Patrick Hull
• Correspondent: Patrick Hull; ELEKTA LTD. FLEMING WAY LINAC HOUSE Crawley, West Sussex, GB Rh10 9rr
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-03
• Decision Date: 2012-06-12
• Summary: summary