23Na/1H Head Coil
The 23Na/1H Head Coil is a transmit-and-receive radiofrequency coil for 3 T magnetic resonance imaging and spectroscopy. It excites and detects signals from sodium-23 and hydrogen-1 nuclei…
The 23Na/1H Head Coil is a transmit-and-receive radiofrequency coil for 3 T magnetic resonance imaging and spectroscopy. It excites and detects signals from sodium-23 and hydrogen-1 nuclei in the head.
The coil applies a radiofrequency magnetic field to excite the nuclei. Their response induces a voltage in the coil that the MR system uses as the detected signal. The coil acts as the radiofrequency interface between the scanner and patient.
Scanner Configuration
The head-coil family has configurations for compatible Siemens, Philips or GE 3 T MR systems. The sodium/hydrogen version is one dual-tuned configuration; separate phosphorus/hydrogen and carbon/hydrogen coils use different nucleus combinations.
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 | Rapid Biomedical Gmbh, Germany |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Manufacturer |
| 510(k) | K213480 |
| Record published | 2023-02-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 5 to 95 % RH; Storage environment humidity 5 to 95 % RH; Handling environment temperature -25 to 60 °C; Storage environment temperature -25 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02016 | In distribution | |
| 02004 | In distribution | |
| 02154 | In distribution | |
| 02001 | In distribution | |
| 02013 | In distribution | |
| 02018 | In distribution | |
| 02007 | 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 |
|---|---|
| K213480 | 2023-02-01 |
| K191539 | 2020-01-31 |
| K181948 | 2018-11-16 |
| K163661 | 2018-03-21 |
| K102748 | 2011-05-13 |
| K102348 | 2010-12-22 |
| K083255 | 2008-11-21 |
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.