Data / Medical devices / United States / Neocoil, LLC
Neocoil, LLC: FDA-registered device maker in Pewaukee, WI, United States, 19 510(k) clearances
Neocoil, LLC is registered with the FDA (registration 3006369484) in Pewaukee, WI, United States. It lists 2 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 23, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006369484
- Address
- N27 W23910a Paul RD., Pewaukee, WI, United States, 53072
- Owner or operator
- NeoCoil, LLC (9099325)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- July 2, 2007
- Registered through
- 2026
- Brand names listed
- 1.5T 16ch Breast Coil, 1.5T 16ch Flex SPEEDER, 1.5T 16ch Shoulder Coil, 1.5T 32ch AIR Open Coil Suite, 1.5T AIR Open Head Anterior 16ch, 1.5T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch, 1.5T Flex Coil for Siemens and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2026 | K260947 | 0.55T 12Ch Breast Coil | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| October 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 Breast Coil | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| March 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 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 | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| June 2, 2020 | K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| November 16, 2018 | K182958 | 1.5T 16ch Breast Coil | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| February 16, 2018 | K173409 | Wireless Audio System | LNH | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| November 28, 2017 | K173377 | 3.0T 16ch Breast Coil | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| July 31, 2014 | K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| July 24, 2014 | K133670 | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE | LNH | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| December 26, 2013 | K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| March 28, 2013 | K123272 | 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| June 15, 2012 | K121362 | 1.5T 16CH FLEX SPEEDER LARGE | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| March 16, 2012 | K113474 | 1.5T GEM FLEX COIL | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| December 23, 2010 | K103342 | 3.0T METAFLEXCOIL | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| August 24, 2010 | K101632 | METAFLEXCOIL | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| November 30, 2007 | K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE | MOS | Substantially Equivalent | Neocoil | accessdata.fda.gov |
| June 28, 2007 | K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL | MOS | Substantially Equivalent | Neocoil | accessdata.fda.gov |
| May 22, 2007 | K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL | MOS | Substantially Equivalent | Neocoil | accessdata.fda.gov |
| April 11, 2007 | K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL | MOS | Substantially Equivalent | Neocoil | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 17, 2016 | 74477 | Class II | Terminated | 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 proton precession in | There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. | accessdata.fda.gov |
| December 18, 2015 | 72976 | Class II | Terminated | 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 5430008-5. 3.0T GEM Flex | Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
Updated April 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.