3.0t 16ch Breast Coil
The NeoCoil 3.0T 16ch Breast Coil receives MRI signals for imaging the breast, axilla and chest wall with compatible GEHC 3.0T scanners. Its phased array is tuned to the radiofrequency…
The NeoCoil 3.0T 16ch Breast Coil receives MRI signals for imaging the breast, axilla and chest wall with compatible GEHC 3.0T scanners. Its phased array is tuned to the radiofrequency associated with hydrogen proton precession in a 3-tesla magnetic field.
The three-part coil assembly includes a coil support, patient support, biopsy components and comfort pads. It is used to obtain diagnostic and interventional planning images interpreted by a trained physician.
Listed Item
The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.
Interventional Access
When fitted with its biopsy components, the coil permits access to breast anatomy for interventional procedures performed by a trained physician. This configuration combines the imaging support structure with access needed for those procedures.
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (2), Tianjin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | Tianjin | Specification developer | 3 |
| Shenzhen RF Tech Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 2 |
| Shanghai Chenguang Medical Technologies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Shanghai Chenshi Medical Instruments Co., Ltd. | Shanghai | Shanghai | Exporter | 2 |
Record
| Listed by | Neocoil, LLC, United States |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K173377 |
| Record published | 2018-04-26 |
| Record revised | 2025-05-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dunlee Sentinelle | Philips Medical Systems Nederland B.V. | 192 |
| Invivo | Philips DS North America LLC | 185 |
| Philips | Philips DS North America LLC | 88 |
| Coil, Magnetic Resonance, Specialty | Usa Instruments, Inc. | 50 |
| Philips | Shanghai Chenguang Medical Technologies Co., Ltd. | 50 |
| GE | Philips DS North America LLC | 41 |
| MR Coils | Philips Medical Systems Nederland B.V. | 37 |
| MRI Coils | Philips DS North America LLC | 24 |
| DuoFLEX® Coil Suite | M R Instruments, Inc. | 20 |
| RFT | Shenzhen RF Tech Co., Ltd. | 18 |
| AtamA™ System | Monteris Medical Corp | 17 |
| Philips Sentinelle | Philips Medical Systems Nederland B.V. | 16 |
Showing 12 of 713. All products under Coil, Magnetic Resonance, Specialty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260947 | 2026-04-23 |
| K222407 | 2022-10-14 |
| K213687 | 2022-03-11 |
| K201101 | 2020-06-02 |
| K182958 | 2018-11-16 |
| K173377 | 2017-11-28 |
| K141832 | 2014-07-31 |
| K133422 | 2013-12-26 |
| K123272 | 2013-03-28 |
| K121362 | 2012-06-15 |
| K113474 | 2012-03-16 |
| K103342 | 2010-12-23 |
| K101632 | 2010-08-24 |
| K073236 | 2007-11-30 |
| K073181 | 2007-11-21 |
| K071611 | 2007-06-28 |
| K071311 | 2007-05-22 |
| K070778 | 2007-04-11 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-06-17 | Class II | Nonconforming Material/Component | There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. | 39 (11 US, 28 OUS) | 2017-11-21 |
| 2015-12-18 | Class II | Component change control | Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. | 2121 | 2016-10-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.