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 IDK111676
510k NumberK111676
Device Name:APEX
ClassificationBlock, Beam-shaping, Radiation Therapy
Applicant Elekta Limited LINAC HOUSE, FLEMING WAY Crawley,  GB Rh10 9rr
ContactPatrick Hull
CorrespondentPatrick Hull
Elekta Limited LINAC HOUSE, FLEMING WAY Crawley,  GB Rh10 9rr
Product CodeIXI  
CFR Regulation Number892.5710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-15
Decision Date2011-09-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060191071215 K111676 000

Trademark Results [APEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
APEX
APEX
98457746 not registered Live/Pending
S. Rays, Inc.
2024-03-19
APEX
APEX
98447337 not registered Live/Pending
Rekluse Racing, LLC
2024-03-13
APEX
APEX
98446915 not registered Live/Pending
Rekluse Racing, LLC
2024-03-13
APEX
APEX
98403162 not registered Live/Pending
Fisher, Mark
2024-02-13
APEX
APEX
98391384 not registered Live/Pending
Hays, Joshua P
2024-02-05
APEX
APEX
98366100 not registered Live/Pending
Fuse Diagnostics Limited
2024-01-19
APEX
APEX
98331556 not registered Live/Pending
Mizuho Corporation
2023-12-27
APEX
APEX
98300144 not registered Live/Pending
Clarion Events, Inc.
2023-12-05
APEX
APEX
98287817 not registered Live/Pending
Fintegra, LLC
2023-11-28
APEX
APEX
98224866 not registered Live/Pending
Indianapolis Bar Association Inc.
2023-10-16
APEX
APEX
98202697 not registered Live/Pending
ispace, Inc.
2023-09-28
APEX
APEX
98157696 not registered Live/Pending
Opener LLC
2023-08-30

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