OR Head Holder Lucy With HeadCoilSet Philips 1.5t
The OR Head Holder Lucy secures the patient's head during neurosurgery and can be combined with a compatible head-coil set for intraoperative MRI. Three skull pins provide the fixation. The…
The OR Head Holder Lucy secures the patient’s head during neurosurgery and can be combined with a compatible head-coil set for intraoperative MRI. Three skull pins provide the fixation.
The frame allows height adjustment and movement parallel to the scanner bore for patient positioning. It supports prone, lateral and supine setups and is designed for use with specified MRI and CT scanner configurations.
Listed Item
The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.5T/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery. The OR Head Holder LUCY is used for safe securing the patient’s head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging, in the X-ray environment it is mandatory to remove the Head Coils and the device serves as a skull clamp only.
Imaging Configuration
The head coils provide MR imaging during open-skull surgery, including the listed Philips 1.5-tesla configuration. For CT or C-arm fluoroscopy, the coils must be removed and the device functions as a skull clamp. The holder and imaging coils therefore have distinct roles within the surgical setup.
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) | K211658 |
| 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 | |
| 02 | 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.