Company ยท US
Neocoil, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 2026 | K260947 | 0.55T 12Ch Breast Coil Neocoil, LLC | MOS |
| Oct 14, 2022 | K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breas Neocoil, LLC | MOS |
| Mar 11, 2022 | K213687 | 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 N Neocoil, LLC | MOS |
| Jun 2, 2020 | K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil Neocoil, LLC | MOS |
| Nov 16, 2018 | K182958 | 1.5T 16ch Breast Coil Neocoil, LLC | MOS |
| Feb 16, 2018 | K173409 | Wireless Audio System Neocoil, LLC | LNH |
| Nov 28, 2017 | K173377 | 3.0T 16ch Breast Coil Neocoil, LLC | MOS |
| Jun 16, 2016 | K160350 | ECG CT Gating Device Neocoil, LLC | JAK |
| Jul 31, 2014 | K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE Neocoil, LLC | MOS |
| Jul 24, 2014 | K133670 | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE Neocoil, LLC | LNH |
| Dec 26, 2013 | K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE Neocoil, LLC | MOS |
| Mar 28, 2013 | K123272 | 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM Neocoil, LLC | MOS |
| Jun 15, 2012 | K121362 | 1.5T 16CH FLEX SPEEDER LARGE Neocoil, LLC | MOS |
| Mar 16, 2012 | K113474 | 1.5T GEM FLEX COIL Neocoil, LLC | MOS |
| Dec 23, 2010 | K103342 | 3.0T METAFLEXCOIL Neocoil, LLC | MOS |
| Aug 24, 2010 | K101632 | METAFLEXCOIL Neocoil, LLC | MOS |
| Nov 30, 2007 | K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE Neocoil | MOS |
| Nov 21, 2007 | K073181 | NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL Neocoil, LLC | MOS |
| Jun 28, 2007 | K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL Neocoil | MOS |
| May 22, 2007 | K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL Neocoil | MOS |
| Apr 11, 2007 | K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL Neocoil | MOS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2016 | NeoCoil, LLC 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the Terminated |
MOS | K141832 |
| Dec 18, 2015 | NeoCoil, LLC NeoCoil 3.0T GEM Flex Coil.
The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box.
3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 543 Terminated |
MOS | K103342 |