Invivo
BREAST 7 BIOPSY PACK 1.5T contains - 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub…
BREAST 7 BIOPSY PACK 1.5T contains – 3 LBS M-L Grid Immobilization Plates; 3 LBS M-L Pillar Immobilization Plates Sterilized; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assemblies; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 LBS C-C Grid Immobilization Plates Sterilized; 3 LBS C-C Pillar Immobilization Plates Sterilized; 2 Biopsy Fiducial Markers; MRI Needle Sleeve 16G; Fiducial Marker Block; 2 Needle Block Holder.
9manufacturers in China registered for this device type
185catalogue 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) | K213351 |
| Record published | 2016-09-23 |
| Record revised | 2025-09-25 (version 12) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Liquid Chemical |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 100 % RH; Storage environment temperature -40 to 70 °C |
| Distribution end date | 2025-02-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45353006696 | In distribution | |
| dS Microscopy 47mm Coil, Ingenia 3.0T | In distribution | |
| 543GE-64 | In distribution | |
| 45353022887 | In distribution | |
| Lateral Grid, Lower dS Breast 16CH I/T | In distribution | |
| dS Base 3.0T | In distribution | |
| 459801729961 | In distribution | |
| Knee Speeder | In distribution | |
| dS FootAnkle 16Ch 1.5T | In distribution | |
| 108547 | In distribution | |
| 108365 | In distribution | |
| 45353028073 | In distribution | |
| dS FLEX-S 1.5T | In distribution | |
| 101078 | In distribution | |
| 108625 | In distribution | |
| SENSE Spine 8 | In distribution | |
| Lateral Grid, Upper dS Breast 16CH I/T | In distribution | |
| 45353024710 | In distribution | |
| 45353026479 | In distribution | |
| 459801729901 | In distribution | |
| 459801729911 | In distribution | |
| 103345 | In distribution | |
| 4535-303-8520 | In distribution | |
| 45980011839 | In distribution | |
| 45353028072 | In distribution | |
| Biopsy Grid Package (User-sterilized) | In distribution | |
| Biopsy Grid (User-sterilized) | In distribution | |
| 45980009797 | In distribution | |
| dS HiRes Hand/Wrist 16Ch 1.5T | In distribution | |
| 459801730011 | In distribution | |
| 45353033814 | In distribution | |
| 45353023752 | In distribution | |
| 45353024709 | In distribution | |
| 45353021516 | In distribution | |
| 9896-032-07292 | In distribution | |
| 459801794481 | In distribution | |
| 45353028270 | In distribution | |
| 45353007107 | In distribution | |
| 45353005369 | In distribution | |
| 45353031605 | In distribution | |
| 109230 | In distribution | |
| 45353038449 | In distribution | |
| 45353003372 | In distribution | |
| 45980087863 | In distribution | |
| 45353020260 | In distribution | |
| 104461 | In distribution | |
| SENSE MSK M 8ch 1.5T | In distribution | |
| dS Shoulder 16Ch 1.5T | In distribution | |
| 45353025227 | In distribution | |
| Biopsy Grid | In distribution | |
| 45353030967 | In distribution | |
| 45353030968 | In distribution | |
| 45980077811 | In distribution | |
| 45353005457 | In distribution | |
| 45353032312 | In distribution | |
| dS Breast 7ch 3.0T | In distribution | |
| 459801729981 | In distribution | |
| 45353010411 | In distribution | |
| 4535-303-8608 | In distribution | |
| 101966 | In distribution | |
| 45353020838 | In distribution | |
| 106538 | In distribution | |
| 45353008930 | In distribution | |
| 45353005458 | In distribution | |
| dS Breast 16ch 3.0T | In distribution | |
| 585TO-64 | In distribution | |
| 45980129100 | In distribution | |
| 45353028316 | In distribution | |
| dS T/R Knee 16ch 3.0T | In distribution | |
| 98960320357 | In distribution | |
| SENSE Head 8 | In distribution | |
| 105411 | In distribution | |
| 45353022888 | In distribution | |
| 45980009798 | In distribution | |
| 45980129091 | In distribution | |
| dS Head 1.5T | In distribution | |
| dS Head 32ch 3.0T | In distribution | |
| dS Knee 16Ch 1.5T | In distribution | |
| 45353038409 | In distribution | |
| Sentinelle SMS 4ch Breast 1.5T | In distribution | |
| 459801729951 | In distribution | |
| 100818 | In distribution | |
| 45353033618 | In distribution | |
| Medial Grid dS Breast 16CH I/T | In distribution | |
| SENSE Head 16 | In distribution | |
| SENSE Spine 16 | In distribution | |
| 45980009796 | In distribution | |
| 101181 | In distribution | |
| 45353022873 | In distribution | |
| 45980009795 | In distribution | |
| 45353033813 | In distribution | |
| 45353025226 | In distribution | |
| 45353028088 | In distribution | |
| dS Base 1.5T | In distribution | |
| 45353032313 | In distribution | |
| 45353009654 | In distribution | |
| 459801729941 | In distribution | |
| 45353005370 | In distribution | |
| 45353022889 | In distribution | |
| 45353027437 | In distribution | |
| 109183 | In distribution | |
| 9896-032-07973 | In distribution | |
| 45353010280 | In distribution | |
| dS Shoulder 16Ch 3.0T | In distribution | |
| 45980011840 | In distribution | |
| 103869 | In distribution | |
| dS HiRes Hand/Wrist 16Ch 3.0T | In distribution | |
| 45353010414 | In distribution | |
| SENSE Torso 16 | In distribution | |
| 45353005601 | In distribution | |
| 104788 | In distribution | |
| DS FLEX-M 3.0T | In distribution | |
| 106394 | In distribution | |
| 109961 | In distribution | |
| dS Anterior 3.0T | In distribution | |
| 45353009284 | In distribution | |
| dS HeadNeck 3.0T | In distribution | |
| dS Small Extremity 16Ch 1.5T | In distribution | |
| 45980009794 | In distribution | |
| 45353028317 | In distribution | |
| 101133 | In distribution | |
| dS FLEX-L 1.5T | In distribution | |
| 459801728831 | In distribution | |
| SENSE Torso 8 | In distribution | |
| 45353032128 | In distribution | |
| 45353006520 | In distribution | |
| 459801728821 | In distribution | |
| 45353022877 | In distribution | |
| 45353022871 | In distribution | |
| 101463 | In distribution | |
| Breast Speeder | In distribution | |
| 585GE-64 | In distribution | |
| 101759 | In distribution | |
| dS Small Extremity 16Ch 3.0T | In distribution | |
| 9896-031-10735 | In distribution | |
| 544GE-64 | In distribution | |
| dS Breast 16ch 1.5T | In distribution | |
| Lateral Grid dS Breast 16CH I/T | In distribution | |
| dS Breast 7ch 1.5T | In distribution | |
| 100824 | In distribution | |
| 109670 | In distribution | |
| 108546 | In distribution | |
| 45353025229 | In distribution | |
| dS FLEX-L 3.0T | In distribution | |
| 45353033617 | In distribution | |
| 45353025708 | In distribution | |
| 45353033611 | In distribution | |
| 103344 | In distribution | |
| dS FLEX-S | In distribution | |
| 45353028304 | In distribution | |
| 100851 | In distribution | |
| 459801729991 | In distribution | |
| 459801795041 | In distribution | |
| 45980009799 | In distribution | |
| 45353007127 | In distribution | |
| 45353024714 | In distribution | |
| 101267 | In distribution | |
| dS Anterior 1.5T | In distribution | |
| 45353025267 | In distribution | |
| 45353006557 | In distribution | |
| 45353033616 | In distribution | |
| 45353032314 | In distribution | |
| 45353033812 | In distribution | |
| 45353033613 | In distribution | |
| 109188 | In distribution | |
| dS FootAnkle 16Ch 3.0T | In distribution | |
| 459801729931 | In distribution | |
| dS HeadNeck 1.5T | In distribution | |
| 109246 | In distribution | |
| 45353024713 | In distribution | |
| 45353025228 | In distribution | |
| 103491 | In distribution | |
| dS FLEX-M 1.5T | In distribution | |
| 45980133160 | In distribution | |
| 103134 | In distribution | |
| Biopsy Grid | In distribution | |
| 108542 | In distribution | |
| 45353031238 | In distribution | |
| 45353033612 | In distribution | |
| 45353028089 | In distribution | |
| 45353027439 | In distribution | |
| 45353022891 | In distribution | |
| 45353022875 | In distribution | |
| dS Head 3.0T | In distribution | |
| Grid Immobilization Plate OBC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dunlee Sentinelle | Philips Medical Systems Nederland B.V. | 192 |
| 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 |
| Dunlee | Philips Medical Systems Nederland B.V. | 16 |
Showing 12 of 713. All products under Coil, Magnetic Resonance, Specialty
Recalls Naming This Product
11 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 |
| 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.