1.5t 16‐channel Flex Coils for Siemens, Large
The 1.5T 16-Channel Flex Coil for Siemens is a receive-only phased-array coil used with compatible Siemens Magnetom MRI scanners. It produces diagnostic images of extremities, chest,…
The 1.5T 16-Channel Flex Coil for Siemens is a receive-only phased-array coil used with compatible Siemens Magnetom MRI scanners. It produces diagnostic images of extremities, chest, abdomen, pelvis and spine for physician interpretation.
The flexible, detachable antennae can wrap around anatomy or lie flat to fit different shapes and sizes. They receive radiofrequency signals corresponding to proton precession at a 1.5 tesla field strength.
Listed Item
The NeoCoil 1.5T 16‐Channel Flex Coils for Siemens is a system of phased array, receive only coils forr imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
Scanner Interface
The system uses Siemens-specific electrical interfaces, cables and connectors. Optional accessories assist patient comfort and motion control, while the matched scanner provides the imaging acquisition environment.
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) | K133422 |
| Record published | 2017-03-21 |
| Record revised | 2020-03-05 (version 5) |
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 |
|---|---|---|
| 44 | 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.