Philips
SYN. Body Coil 1.5T ODU With Sleeve
9manufacturers in China registered for this device type
50catalogue numbers in this listing
8510(k) clearances naming this product code
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 | Shanghai Chenguang Medical Technologies Co., Ltd., China |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K101949 |
| Record published | 2016-09-24 |
| Record revised | 2020-12-21 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4522-133-17141 | In distribution | |
| 4522-133-18721 | In distribution | |
| 4522-150-40972 | In distribution | |
| 4522-133-17271 | In distribution | |
| 4598-000-51941 | In distribution | |
| 4522-133-17261 | In distribution | |
| 4598-000-51841 | In distribution | |
| 4522-133-17151 | In distribution | |
| 4598-000-51951 | In distribution | |
| 4598-000-51893 | In distribution | |
| 4522-133-17251 | In distribution | |
| 4598-000-51921 | In distribution | |
| 4598-000-51894 | In distribution | |
| 4522-133-17272 | In distribution | |
| 4598-000-51971 | In distribution | |
| 4598-000-51871 | In distribution | |
| 4522-133-17201 | In distribution | |
| 4598-000-51873 | In distribution | |
| 4522-150-41161 | In distribution | |
| 4598-000-51872 | In distribution | |
| 4598-000-20681 | In distribution | |
| 4598-000-51822 | In distribution | |
| 4522-133-18981 | In distribution | |
| 4522-133-17162 | In distribution | |
| 4522-133-17231 | In distribution | |
| 4598-000-20661 | In distribution | |
| 4598-000-20651 | In distribution | |
| 4598-001-52231 | In distribution | |
| 4598-000-51821 | In distribution | |
| 4598-000-51961 | In distribution | |
| 4522-133-17181 | In distribution | |
| 4598-000-51911 | In distribution | |
| 4522-133-17191 | In distribution | |
| 4598-002-05291 | In distribution | |
| 4598-000-52031 | In distribution | |
| 4522-133-17211 | In distribution | |
| 4598-009-69781 | In distribution | |
| 4598-000-51831 | In distribution | |
| 4598-000-51892 | In distribution | |
| 4522-150-41021 | In distribution | |
| 4598-000-51892 | In distribution | |
| 4598-000-51981 | In distribution | |
| 4598-000-51931 | In distribution | |
| 4598-000-20671 | In distribution | |
| 4598-000-51991 | In distribution | |
| 4522-133-17172 | In distribution | |
| 4522-150-41131 | In distribution | |
| 4598-000-51811 | In distribution | |
| 4522-133-17221 | In distribution | |
| 4522-133-17242 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112002 | 2011-11-18 |
| K101949 | 2010-07-28 |
| K101858 | 2010-07-14 |
| K092962 | 2009-10-09 |
| K081340 | 2008-06-18 |
| K081322 | 2008-06-18 |
| K071847 | 2007-07-23 |
| K071882 | 2007-07-18 |
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.