APEX

Block, Beam-shaping, Radiation Therapy

Elekta Limited

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

Pre-market Notification Details

• Device ID: K111676
• 510k Number: K111676
• Device Name: APEX
• Classification: Block, Beam-shaping, Radiation Therapy
• Applicant: Elekta Limited LINAC HOUSE, FLEMING WAY Crawley, GB Rh10 9rr
• Contact: Patrick Hull
• Correspondent: Patrick Hull; Elekta Limited LINAC HOUSE, FLEMING WAY Crawley, GB Rh10 9rr
• Product Code: IXI
• CFR Regulation Number: 892.5710 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-15
• Decision Date: 2011-09-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060191071215	K111676	000