1.5t GEM Flex Coil 16-M Array
1.5T GEM Flex Coil 16-M Array: 1 catalogue number listed by Neocoil, LLC, United States, under Coil, Magnetic Resonance, Specialty. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
18510(k) clearances naming this product code
2recalls on this code
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) | K113474 |
| 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 |
|---|---|---|
| 08 | 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.