Na-140-Flex Coil
2 catalogue numbers from 45980170623x, listed by Rapid Biomedical Gmbh, Germany, under Coil, Magnetic Resonance, Specialty. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
2catalogue numbers in this listing
7510(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 | Rapid Biomedical Gmbh, Germany |
|---|---|
| FDA product code | MOS |
| Device type | Coil, Magnetic Resonance, Specialty |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| Establishment | Manufacturer |
| 510(k) | K163661 |
| Record published | 2020-12-15 |
| Record revised | 2020-12-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment temperature -25 to 60 °C; Handling environment humidity 40 to 80 % RH; Handling environment temperature 18 to 24 °C |
| Distribution end date | 2020-12-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45980170623x | In distribution | |
| 01790 | Withdrawn |
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 |
|---|---|
| K213480 | 2023-02-01 |
| K191539 | 2020-01-31 |
| K181948 | 2018-11-16 |
| K163661 | 2018-03-21 |
| K102748 | 2011-05-13 |
| K102348 | 2010-12-22 |
| K083255 | 2008-11-21 |
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.