Breast BI Coil Set 0.55t
The Breast BI Coil Set 0.55T is used with a compatible Siemens 0.55T MRI scanner to image the female breast. Its images support diagnosis when interpreted by a trained physician. The set…
The Breast BI Coil Set 0.55T is used with a compatible Siemens 0.55T MRI scanner to image the female breast. Its images support diagnosis when interpreted by a trained physician. The set also includes a biopsy unit for MR-guided breast biopsy and placement of localization wires.
A seven-channel phased array receives radiofrequency signals from hydrogen nuclei excited by the scanner’s transmit coil. The received signals are digitized and processed by the MRI system. A rigid frame holds the receive coils along with the breast positioning and biopsy components.
Construction
The frame uses fiberglass-reinforced polycarbonate with a biocompatible surface coating. The breast cushion and headrest are polyethylene. The 0.55T set is distinct from the family’s separate 1.5T and 3T configurations.
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 | Noras MRI products GMBH, Germany |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K220144 |
| Record published | 2022-05-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01 | 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 |
|---|---|
| K241069 | 2024-06-07 |
| K220144 | 2022-04-08 |
| K211658 | 2022-03-03 |
| K180123 | 2018-02-16 |
| K133506 | 2014-08-06 |
| K093693 | 2010-01-19 |
| K091546 | 2009-06-24 |
| K083578 | 2009-01-16 |
| K082373 | 2008-08-29 |
| K081118 | 2008-05-02 |
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.