3t 16ch Flex Speeder Medium
The 3T 16ch Flex Speeder Medium is part of a receive-only phased-array MRI coil system for diagnostic imaging with compatible Toshiba 3T scanners. The coils support imaging of extremities,…
The 3T 16ch Flex Speeder Medium is part of a receive-only phased-array MRI coil system for diagnostic imaging with compatible Toshiba 3T scanners. The coils support imaging of extremities, chest, abdomen, pelvis, head, neck and spine.
Flexible, detachable antennae can wrap around anatomy or lie flat to accommodate different shapes and sizes. They are tuned to receive the radiofrequency signal corresponding to proton precession in a 3 tesla magnetic field.
Listed Item
The NeoCoil 3T l6ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis. head, neck, and spine. The system is compatible with 20, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction.
Scanner and Imaging Compatibility
The system requires Toshiba 3T scanners with ODU connectors. It supports two-dimensional, three-dimensional, parallel and isotropic imaging, together with coil signal-intensity correction; optional accessories assist positioning and comfort.
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) | K141832 |
| Record published | 2017-03-16 |
| Record revised | 2020-03-05 (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 |
|---|---|---|
| 25 | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Neocoil, LLC | 510(k) number | 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 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 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.