31P/1H Head Coil
31P/1H Head Coil is a dual-tuned transmit-and-receive coil for magnetic resonance imaging and spectroscopy with compatible 3T MRI systems. It excites and detects hydrogen and phosphorus…
31P/1H Head Coil is a dual-tuned transmit-and-receive coil for magnetic resonance imaging and spectroscopy with compatible 3T MRI systems. It excites and detects hydrogen and phosphorus nuclei in the head.
The coil applies a radiofrequency magnetic field for excitation and receives the voltage induced by the observed nuclei. Its antenna technology links the MR system and the patient for imaging and spectroscopic acquisition.
Scanner Compatibility
The head-coil range is designed for specified Siemens, Philips or GE 3.0T systems. The matching scanner and coil configuration determine the supported interface; the phosphorus-hydrogen version serves the corresponding dual-nucleus measurements.
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; Storage environment temperature -25 to 60 °C; Handling environment temperature -25 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02003 | In distribution | |
| 02012 | In distribution | |
| 02153 | In distribution | |
| 02006 | In distribution | |
| 02104 | In distribution | |
| 02000 | In distribution | |
| 02015 | 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.