CLARITY

Accelerator, Linear, Medical

ELEKTA LTD.

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

Pre-market Notification Details

• Device ID: K121663
• 510k Number: K121663
• Device Name: CLARITY
• Classification: Accelerator, Linear, Medical
• Applicant: ELEKTA LTD. 2050 BLEURY, SUITE 200 Montreal, CA H3a 2j5
• Contact: George Papagiannis
• Correspondent: George Papagiannis; ELEKTA LTD. 2050 BLEURY, SUITE 200 Montreal, CA H3a 2j5
• Product Code: IYE
• Subsequent Product Code: IWB
• Subsequent Product Code: KPQ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-05
• Decision Date: 2012-12-05
• Summary: summary