13C/1H Head Coil
The 13C/1H Head Coil is an accessory for magnetic resonance imaging and spectroscopy of the head. It transmits and receives radiofrequency signals for hydrogen and carbon nuclei, linking…
The 13C/1H Head Coil is an accessory for magnetic resonance imaging and spectroscopy of the head. It transmits and receives radiofrequency signals for hydrogen and carbon nuclei, linking the patient with a compatible magnetic resonance system. It is designed for specified 3 tesla Siemens, Philips or GE systems.
The coil applies a radiofrequency magnetic field to excite the nuclei being examined. Their response induces a radiofrequency voltage in the coil, which the scanner receives as a signal. This transmit and receive arrangement supports measurements using the two tuned nuclear frequencies.
System Compatibility
The coil is part of the Dual Tuned Head Coil 3T range. Each coil configuration must be used with the magnetic resonance system for which its labelling is specified.
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 |
|---|---|---|
| 02017 | In distribution | |
| 02002 | In distribution | |
| 02014 | In distribution | |
| 02105 | In distribution | |
| 02005 | In distribution | |
| 02008 | In distribution | |
| 02155 | 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.