FDA 510(k) Applications Submitted by NeoCoil, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K101632 |
06/10/2010 |
METAFLEXCOIL |
NEOCOIL, LLC |
| K073181 |
11/13/2007 |
NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL |
NEOCOIL, LLC |
| K103342 |
11/15/2010 |
3.0T METAFLEXCOIL |
NEOCOIL, LLC |
| K201101 |
04/24/2020 |
1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil |
NeoCoil, LLC |
| K222407 |
08/09/2022 |
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil |
NeoCoil, LLC |
| K123272 |
10/19/2012 |
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM |
NEOCOIL, LLC |
| K182958 |
10/24/2018 |
1.5T 16ch Breast Coil |
NeoCoil, LLC |
| K133422 |
11/08/2013 |
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE |
NEOCOIL, LLC |
| K213687 |
11/23/2021 |
32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch |
NeoCoil, LLC |
| K160350 |
02/08/2016 |
ECG CT Gating Device |
NEOCOIL, LLC |
| K141832 |
07/07/2014 |
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE |
NEOCOIL, LLC |
| K173377 |
10/30/2017 |
3.0T 16ch Breast Coil |
NeoCoil, LLC |
| K173409 |
11/01/2017 |
Wireless Audio System |
NeoCoil, LLC |
| K133670 |
11/29/2013 |
HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE |
NEOCOIL, LLC |
| K121362 |
05/07/2012 |
1.5T 16CH FLEX SPEEDER LARGE |
NEOCOIL, LLC |
| K113474 |
11/22/2011 |
1.5T GEM FLEX COIL |
NEOCOIL, LLC |
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