Philips
Breast MRI 16ch Tabletop for Siemens 1.5T
9manufacturers in China registered for this device type
88catalogue numbers in this listing
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 DS North America LLC, United States |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K112112 |
| Record published | 2019-02-28 |
| Record revised | 2026-01-16 (version 11) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment temperature 5 to 70 °C; Storage environment atmospheric pressure 70 to 110 KiloPascal |
| Distribution end date | 2025-02-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS HIRES HAND/WRIST 16CH 3.0T | In distribution | |
| dS Microscopy 23mm Coil, Ingenia 3.0T | In distribution | |
| SENSE NV Coil 1.5T/16ch | In distribution | |
| DS SMALL EXTREMITY 16CH 3.0T | In distribution | |
| dS Shoulder Coil 8ch 1.5T | In distribution | |
| SENSE Torso/Cardiac Posterior Coil | In distribution | |
| Achieva TX Interventional Coil 3.0T | In distribution | |
| dS Flex-S 1.5T | In distribution | |
| sentinelle TMS endo 1.5T | In distribution | |
| dS Flex-S 3.0T | In distribution | |
| SENSE XL Torso Coil | In distribution | |
| SENSE Foot-ankle coil | In distribution | |
| dS Knee 8ch 3.0T | In distribution | |
| dS Knee 8ch 1.5T | In distribution | |
| dS FootAnkle Coil 8ch 1.5T | In distribution | |
| SENSE Torso/Cardiac Anterior Coil | In distribution | |
| SENSE XL Torso Coil Posterior | In distribution | |
| dS Flex-M 3.0T | In distribution | |
| dS Head 1.5T | In distribution | |
| dS Microscopy 47mm Coil, Ingenia 1.5T | In distribution | |
| dS Breast 7ch 3.0T | In distribution | |
| dS Anterior 1.5T | In distribution | |
| SENSE Small Extremity 3.0T 8 | In distribution | |
| dS Breast Coil 7ch 1.5T | In distribution | |
| SENSE Torso/Cardiac Anterior Coil | In distribution | |
| dS FootAnkle 8ch 3.0T | In distribution | |
| 4ch SENSE Shoulder Coil 1.5T | In distribution | |
| SENSE XL Torso Coil | In distribution | |
| dS Breast 16ch 1.5T | In distribution | |
| SENSE Breast Coil | In distribution | |
| SENSE Shoulder Coil 3.0T | In distribution | |
| dS Anterior 3.0T | In distribution | |
| SENSE MSK S 8ch 1.5T | In distribution | |
| dS FootAnkle 16Ch 3.0T | In distribution | |
| dS SmallExtr 8ch 1.5T | In distribution | |
| dS Base 3.0T | In distribution | |
| SENSE Wrist Coil 1.5T 8ch | In distribution | |
| dS Shoulder 8 ch 3.0T | In distribution | |
| SENSE NV Coil 1.5T/8ch | In distribution | |
| dS Small Extremity 16Ch 1.5T | In distribution | |
| dS T/R Knee 16ch 3.0T | In distribution | |
| dS Flex-M 1.5T | In distribution | |
| Breast MRI 8ch Table for GE 1.5T | In distribution | |
| dS Headneck 3.0T | In distribution | |
| dS Base 1.5T | In distribution | |
| dS Head 32ch 3.0T | In distribution | |
| SENSE Foot-ankle coil | In distribution | |
| 1.5T SENSE GP Flex 8 | In distribution | |
| dS HiRes Hand/Wrist 16Ch 1.5T | In distribution | |
| SENSE Spine Coil 1.5T 15-ch | In distribution | |
| dS Breast 16ch 3.0T | In distribution | |
| dS Headneck 1.5T | In distribution | |
| SENSE Knee Coil 3.0T/8ch | In distribution | |
| SENSE Shoulder Coil 1.5T | In distribution | |
| SENSE Knee Coil 16ch TX | In distribution | |
| dS Flex-L 3.0T | In distribution | |
| SENSE Head Coil 1.5T/8ch | In distribution | |
| dS FootAnkle 16Ch 1.5T | In distribution | |
| dS Wrist 8ch 1.5T | In distribution | |
| ds KNEE 8Ch 3.0T | In distribution | |
| SENSE Knee Coil 16ch | In distribution | |
| dS Knee Coil 8ch 1.5T | In distribution | |
| SENSE NV Coil 3.0T/16ch | In distribution | |
| dS Breast 7ch 1.5T | In distribution | |
| dS Microscopy 23mm Coil, Ingenia 1.5T | In distribution | |
| SENSE Wrist Coil 3.0T 8ch | In distribution | |
| dS Knee 16ch 1.5T | In distribution | |
| SENSE Torso/Cardiac Posterior Coil | In distribution | |
| dS FootAnkle 8ch 1.5T | In distribution | |
| dS Shoulder 16Ch 1.5T | In distribution | |
| dS Shoulder 16Ch 3T | In distribution | |
| dS Shoulder 8ch 1.5T | In distribution | |
| SENSE Spine Coil 3.0T 15-ch | In distribution | |
| dS Flex-L 1.5T | In distribution | |
| dS Wrist 8ch 3.0T | In distribution | |
| dS Head 3.0T | In distribution | |
| SENSE Small Extremity 1.5T 8 | In distribution | |
| SENSE Head Coil 3.0T/8ch | In distribution | |
| SENSE Breast Coil 7ch | In distribution | |
| dS Wrist Coil 8ch 1.5T | In distribution | |
| dS FLEX-S 1.5T | In distribution | |
| SENSE Knee Coil 1.5T/8ch | In distribution | |
| SENSE Head Coil 32ch 3.0T | In distribution | |
| SENSE XL Torso Coil Anterior | In distribution | |
| dS SmallExtr 8ch 3.0T | In distribution | |
| Sentinelle TMS 8ch Breast 3.0T | Withdrawn | |
| Sentinelle SMS endo 3.0T | Withdrawn | |
| Sentinelle SMS 16ch Breast 1.5T | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dunlee Sentinelle | Philips Medical Systems Nederland B.V. | 192 |
| Invivo | Philips DS North America LLC | 185 |
| 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 |
| Dunlee | Philips Medical Systems Nederland B.V. | 16 |
Showing 12 of 713. All products under Coil, Magnetic Resonance, Specialty
Recalls Naming This Product
6 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 |
| 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.