Philips Sentinelle
dS 3.0T 4CH Lateral Right
9manufacturers in China registered for this device type
16catalogue numbers in this listing
6510(k) clearances naming this product code
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) | K213735 |
| Record published | 2024-12-17 |
| Record revised | 2025-09-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 700 to 1100 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -25 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| dS 1.5T 1CH Lateral Left | In distribution | |
| dS 3.0T 1CH Lateral Left | In distribution | |
| dS 1.5T Medial Plug | In distribution | |
| dS 1.5T 4CH Lateral Left | In distribution | |
| dS 3.0T 8CH Medial | In distribution | |
| dS 3.0T Interface Box | In distribution | |
| dS Patient Support | In distribution | |
| dS 3.0T Medial Plug | In distribution | |
| dS 3.0T 4CH Lateral Right | In distribution | |
| dS 1.5T Interface Box | In distribution | |
| dS 1.5T 1CH Lateral Right | In distribution | |
| dS 1.5T 8CH Medial | In distribution | |
| dS 3.0T 1CH Lateral Right | In distribution | |
| dS Headrest | In distribution | |
| dS 1.5T 4CH Lateral Right | In distribution | |
| dS 3.0T 4CH Lateral Left | 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 |
| 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 |
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.