RFT
The 1.5T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It includes of three coils: 16-L Array, 16-M Array,…
The 1.5T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It includes of three coils: 16-L Array, 16-M Array, and 16-S Array. The 1.5T GEM Flex Suite is designed for use with GEHC 1.5T MRI systems to produce diagnostic images of the Head, Torso, Hip, Spine, Shoulder, Knee, Foot, Ankle, Elbow, and Wrist that can be interpreted by a trained physician.
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 | Shenzhen RF Tech Co., Ltd., China |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K160935 |
| Record published | 2016-08-03 |
| Record revised | 2026-03-03 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -30 to 70 °C; Storage environment humidity 5 to 95 % RH |
| Packaging | Carton box, carton |
| Sizes | Height 215 to 325 mm; width 403 mm; depth 358 mm; width 345 µm; length 412 µm |
| Distribution end date | 2022-12-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-F23936 | In distribution | |
| 10-F24262 | In distribution | |
| 10-F25061 | In distribution | |
| 10-F34744 | In distribution | |
| 10-F35780 | In distribution | |
| 10-F35782 | In distribution | |
| 10-F31896 | Width 403 mm | In distribution |
| 10-F34742 | In distribution | |
| 10-F34722 | In distribution | |
| 10-F24260 | In distribution | |
| 10-F25062 | In distribution | |
| 10-F35781 | In distribution | |
| 10-F21457 | In distribution | |
| 10-F25063 | In distribution | |
| 10-F24261 | In distribution | |
| 10-F34743 | In distribution | |
| 10-F34127 | Width 403 mm | In distribution |
| 10-F32119 | Width 345 µm | Withdrawn |
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 |
| AtamA™ System | Monteris Medical Corp | 17 |
| Philips Sentinelle | Philips Medical Systems Nederland B.V. | 16 |
| Dunlee | Philips Medical Systems Nederland B.V. | 16 |
Showing 12 of 713. All products under Coil, Magnetic Resonance, Specialty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252587 | 2026-04-14 |
| K252876 | 2026-04-01 |
| K252179 | 2026-02-10 |
| K231085 | 2023-08-18 |
| K223225 | 2023-02-14 |
| K223239 | 2022-12-08 |
| K200836 | 2020-07-22 |
| K172222 | 2017-12-08 |
| K160932 | 2016-08-01 |
| K160935 | 2016-07-28 |
| K151653 | 2015-08-07 |
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.