Dunlee
The 16 Breast Coil is a Phased Array Receive Only MRI Coil. It is a variable 16 CH Breast coil for both diagnostic imaging and biopsy procedures. The coil consists of a Patient Support, a…
The 16 Breast Coil is a Phased Array Receive Only MRI Coil. It is a variable 16 CH Breast coil for both diagnostic imaging and biopsy procedures. The coil consists of a Patient Support, a Headrest, two 4CH Lateral coils (left and right), an 8CH Medial Array Coil and various other pads and supports.
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) | K222257 |
| Record published | 2026-04-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature 5 to 65 °C; Storage environment humidity 10 to 100 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.0T HD T/R Knee Coil (flat base) | In distribution | |
| 1.5T HD T/R Knee Coil (flat base) | In distribution | |
| 1.5T HD T/R KNEE ARRAY | In distribution | |
| HD T/R QUAD EXTREMITY COIL | In distribution | |
| 8 CHANNEL KNEE COIL | In distribution | |
| HD 8Ch Foot Ankle Coil | In distribution | |
| HD 8Ch WRIST ARRAY (Receive Only) | In distribution | |
| 459801412012 | In distribution | |
| 8 CH HIGH RESOLUTION KNEE ARRAY | In distribution | |
| HD T/R QUAD EXTREMITY COIL | In distribution | |
| 16Ch Shoulder Coil | In distribution | |
| 16 BREAST COIL | In distribution | |
| HD 8Ch Wrist Array | In distribution | |
| 459801430512 | In distribution | |
| 3T HD T/R KNEE ARRAY | In distribution | |
| 3.0T 32Ch Cardiac Coil – Anterior | 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 |
|---|---|
| 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.