MR Coils
The dStream (dS) Base coils are lightweight, 8-channel receive only, phased-array coil that are designed to be used independently or in combination with the dS Head or dS HeadNeck coil. The…
The dStream (dS) Base coils are lightweight, 8-channel receive only, phased-array coil that are designed to be used independently or in combination with the dS Head or dS HeadNeck coil. The dS Base coil can be used for extremities and pediatric examinations or can be combined with the dS Posterior coil which is integrated in the patient support of the compatible MR Systems4 for total spine imaging. The dS Base coil can stay on the table for most examinations without exchanging coils, thereby improving workflow. These coils are available in both 1.5T and 3.0T and are connected with the flex connect socket of the compatible MR System.
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 | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K254190 |
| Record published | 2023-08-15 |
| Record revised | 2026-03-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 70 to 110 KiloPascal; Handling environment humidity 5 to 95 % RH; Handling environment temperature -25 to 70 °C; Storage environment atmospheric pressure 70 to 110 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -25 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| dS Shoulder 16Ch 3.0T | In distribution | |
| SENSE MSK S 8ch 1.5T | In distribution | |
| dS Shoulder Coil 8ch 1.5T | In distribution | |
| dS Breast 16ch 3.0T | In distribution | |
| dS Breast 7ch 3.0T | In distribution | |
| DS FLEX-M 3.0T | In distribution | |
| DS HeadNeck 3.0T | In distribution | |
| DS Base 3.0T | In distribution | |
| dS Shoulder 16Ch 1.5T | In distribution | |
| SENSE MSK M 8ch 1.5T | In distribution | |
| dS FootAnkle 16 CH 3.0T | In distribution | |
| dS Head 32CH 3.0T | In distribution | |
| dS FootAnkle 16 CH 1.5T | In distribution | |
| dS ANTERIOR 3.0T | In distribution | |
| dS FLEX-S | In distribution | |
| DS BASE 1.5T | In distribution | |
| dS Breast Coil 7ch 1.5T | In distribution | |
| dS Breast 7ch 1.5T | In distribution | |
| dS FLEX-L 1.5T | In distribution | |
| dS Breast 16Ch 1.5T | In distribution | |
| dS FootAnkle Coil 8ch 1.5T | In distribution | |
| dS Wrist Coil 8ch 1.5T | In distribution | |
| dS FLEX-L 3.0T | In distribution | |
| dS Small Extremity 16Ch 1.5T | In distribution | |
| DS Head 1.5T | In distribution | |
| DS Head 3.0T | In distribution | |
| DS HeadNeck 1.5T | In distribution | |
| dS FLEX-S 1.5T | In distribution | |
| dS FLEX-M 1.5T | In distribution | |
| dS Knee Coil 16ch 1.5T | In distribution | |
| dS Small Extremity 16Ch 3.0T | In distribution | |
| dS HiRes Hand/Wrist 16Ch 3.0T | In distribution | |
| dS T/R Knee 16ch 3.0T | In distribution | |
| dS Knee Coil 8ch 1.5T | In distribution | |
| dS HiRes Hand/Wrist 16Ch 1.5T | In distribution | |
| 1.5T SENSE GP Flex 8 | In distribution | |
| dS ANTERIOR 1.5T | 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 |
| 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 |
| 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 |
|---|---|
| K262330 | 2026-07-30 |
| K262294 | 2026-07-24 |
| K254190 | 2026-01-14 |
| K243033 | 2024-10-18 |
| K242879 | 2024-10-18 |
| K242096 | 2024-08-12 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2024-11-04 | Class II | Use error | Potential safety issue where a patient may be harmed while preparing for or during a scan. | 5,231 units |
| Philips North America LLC | UDI-DI | 2024-11-04 | Class II | Use error | Potential safety issue where a patient may be harmed while preparing for or during a scan. | 5,231 units |
| Philips North America LLC | UDI-DI | 2024-11-04 | Class II | Use error | Potential safety issue where a patient may be harmed while preparing for or during a scan. | 5,231 units |
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.