The following data is part of a premarket notification filed by Elekta Limited with the FDA for Apex.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060191071215 | K111676 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
APEX 98457746 not registered Live/Pending |
S. Rays, Inc. 2024-03-19 |
APEX 98447337 not registered Live/Pending |
Rekluse Racing, LLC 2024-03-13 |
APEX 98446915 not registered Live/Pending |
Rekluse Racing, LLC 2024-03-13 |
APEX 98403162 not registered Live/Pending |
Fisher, Mark 2024-02-13 |
APEX 98391384 not registered Live/Pending |
Hays, Joshua P 2024-02-05 |
APEX 98366100 not registered Live/Pending |
Fuse Diagnostics Limited 2024-01-19 |
APEX 98331556 not registered Live/Pending |
Mizuho Corporation 2023-12-27 |
APEX 98300144 not registered Live/Pending |
Clarion Events, Inc. 2023-12-05 |
APEX 98287817 not registered Live/Pending |
Fintegra, LLC 2023-11-28 |
APEX 98224866 not registered Live/Pending |
Indianapolis Bar Association Inc. 2023-10-16 |
APEX 98202697 not registered Live/Pending |
ispace, Inc. 2023-09-28 |
APEX 98157696 not registered Live/Pending |
Opener LLC 2023-08-30 |