NeoCoil, LLC
Pewaukee, WI, US
NEOCOIL, LLC appears in FDA device records in Pewaukee, WI. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for NeoCoil, LLC between 2007 and 2026. The busiest year on record is 2007, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 5 |
| 2010 | 2 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2022 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260947 | 0.55T 12Ch Breast Coil | MOS | Substantially Equivalent | |
| 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 | |
| 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 | |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | MOS | Substantially Equivalent | |
| K182958 | 1.5T 16ch Breast Coil | MOS | Substantially Equivalent | |
| K173409 | Wireless Audio System | LNH | Substantially Equivalent | |
| K173377 | 3.0T 16ch Breast Coil | MOS | Substantially Equivalent | |
| K160350 | ECG CT Gating Device | JAK | Substantially Equivalent | |
| K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE | MOS | Substantially Equivalent | |
| K133670 | HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE | LNH | Substantially Equivalent | |
| K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE | MOS | Substantially Equivalent | |
| K123272 | 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM | MOS | Substantially Equivalent | |
| K121362 | 1.5T 16CH FLEX SPEEDER LARGE | MOS | Substantially Equivalent | |
| K113474 | 1.5T GEM FLEX COIL | MOS | Substantially Equivalent | |
| K103342 | 3.0T METAFLEXCOIL | MOS | Substantially Equivalent | |
| K101632 | METAFLEXCOIL | MOS | Substantially Equivalent | |
| K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE | MOS | Substantially Equivalent | |
| K073181 | NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL | MOS | Substantially Equivalent | |
| K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL | MOS | Substantially Equivalent | |
| K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL | MOS | Substantially Equivalent | |
| K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL | MOS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006369484 | 3006369484 | NEOCOIL, LLC | N27 W23910A PAUL RD., Pewaukee, WI 53072 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2312-2016 | 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 a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician. | There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. | Class II | Terminated | |
| Z-1027-2016 | 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 Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner | Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets NeoCoil, LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain