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: K141855
• 510k Number: K141855
• Device Name: CLARITY
• Classification: Accelerator, Linear, Medical
• Applicant: ELEKTA LTD. 2050 BLEURY, SUITE 200 Montreal, Quebec, 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: 2014-07-09
• Decision Date: 2014-10-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07540180000207	K141855	000
07540180000085	K141855	000
07540180000078	K141855	000
07540180000061	K141855	000
07540180000054	K141855	000
07540180000047	K141855	000
07540180000030	K141855	000
07540180000023	K141855	000
07540180000016	K141855	000
07540180000214	K141855	000
07540180000092	K141855	000
07540180000108	K141855	000
07540180000191	K141855	000
07540180000184	K141855	000
07540180000177	K141855	000
07540180000160	K141855	000
07540180000153	K141855	000
07540180000146	K141855	000
07540180000139	K141855	000
07540180000122	K141855	000
07540180000115	K141855	000
07540180000238	K141855	000