Grid Holder CX
Grid Holder CX is an accessory kit used with the Breast SPEEDER CX coil to provide access to breast tissue for biopsy and lesion localization. The combined setup is used with Toshiba 1.5 T…
Grid Holder CX is an accessory kit used with the Breast SPEEDER CX coil to provide access to breast tissue for biopsy and lesion localization. The combined setup is used with Toshiba 1.5 T magnetic resonance systems.
For interventional access, the lateral coils are replaced with a biopsy adapter fitted with a compatible grid or post-and-pillar device. The arrangement permits procedures from either the lateral or medial direction.
Compatible Components
Compatible NORAS components include lateral and medial grids and a reusable pillar-and-post adapter. The Grid Holder CX kit is reusable, and its patient-contact surface is polycarbonate coated with polyurethane enamel.
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 | Quality Electrodynamics, United States |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K142002 |
| Record published | 2016-12-09 |
| Record revised | 2020-03-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MAC000110 | 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 |
|---|---|
| K244054 | 2025-02-28 |
| K233652 | 2024-02-16 |
| K233656 | 2024-02-15 |
| K223429 | 2023-01-13 |
| K200477 | 2020-04-08 |
| K193140 | 2020-01-03 |
| K183111 | 2018-12-07 |
| K181697 | 2018-07-11 |
| K173469 | 2018-01-09 |
| K173446 | 2017-11-17 |
| K162946 | 2017-01-06 |
| K162623 | 2016-12-09 |
| K162966 | 2016-11-30 |
| K163066 | 2016-11-29 |
| K162029 | 2016-10-18 |
| K161193 | 2016-06-02 |
| K152695 | 2015-11-18 |
| K151753 | 2015-08-27 |
| K151829 | 2015-07-29 |
| K150331 | 2015-04-09 |
| K142802 | 2014-11-24 |
| K142002 | 2014-08-22 |
| K140998 | 2014-07-11 |
| K122638 | 2012-09-25 |
| K120627 | 2012-03-29 |
| K120290 | 2012-02-28 |
| K112313 | 2011-09-09 |
| K103185 | 2011-02-25 |
| K093667 | 2010-01-28 |
| K091114 | 2009-05-01 |
| K083160 | 2008-11-07 |
| K082636 | 2008-09-25 |
| K072935 | 2007-10-31 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-08-20 | Class II | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | 3 units | 2020-05-26 |
| 2019-08-20 | Class II | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | 21 units | 2020-05-26 |
| 2019-08-20 | Class II | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | 36 units | 2020-05-26 |
| 2019-08-20 | Class II | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | 3 units | 2020-05-26 |
| 2019-08-20 | Class II | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | 5 units | 2020-05-26 |
| 2019-08-20 | Class II | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | 5 units | 2020-05-26 |
| 2019-08-20 | Class II | Nonconforming Material/Component | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils. | 2 units | 2020-05-26 |
| 2012-07-27 | Class II | Error in labeling | On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect. | 17 units | 2013-02-19 |
| 2008-12-29 | Not classified | Device Design | The firm received a complaint indicating that the mirror is high risk and could drop on a patient. | 5 units | 2012-04-25 |
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.