SwiftMR
SwiftMR is standalone medical-imaging software that processes DICOM-format MR images for review, analysis and transfer. The filing describes an image-enhancement algorithm that reduces…
SwiftMR is standalone medical-imaging software that processes DICOM-format MR images for review, analysis and transfer.
The filing describes an image-enhancement algorithm that reduces noise and increases sharpness in MRI images.
Listed Item
SwiftMR is a stand-alone medical imaging software solution intended for the acceptance, enhancement, processing, review, analysis, communication, and transfer of all body parts MR images in DICOM format. The software may be used for the enhancement of medical images, such as noise reduction and increased image sharpness for MR images. The device is designed for use by healthcare professionals and is intended to assist clinicians, who remain responsible for making all final patient management decisions. The device is not intended for use on mobile devices. The available field strengths are as follows: 0.25T, 0.31T, 0.4T, 0.55T, 0.6T, 1.5T, and 3.0T.
Image-Processing Workflow
Its workflow receives MR images from PACS or an MRI system, processes them, then transfers enhanced DICOM images back to PACS or MRI. The filing identifies the software for professional purposes and excludes use on mobile devices.
Who Else Makes It
Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
| Wuhan United Imaging Healthcare Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
| Keya Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Airs Medical Inc., South Korea |
|---|---|
| FDA product code | QIH |
| Device type | Automated Radiological Image Processing Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K253775 |
| Record published | 2026-04-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A20-CL v3.1.X.X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imbio RV/LV | Imbio, LLC | 5 |
| VEA Align | EOS imaging | 4 |
| Qlab Advanced Quantification Software | Philips Ultrasound LLC | 3 |
| uOmnispace | Shanghai United Imaging Healthcare Co., Ltd. | 3 |
| Scenium | Siemens Medical Solutions USA, Inc. | 3 |
| syngo.MI General | Siemens Medical Solutions USA, Inc. | 3 |
| Neosoma Dashboard | Neosoma, Inc. | 3 |
| BriefCase-Quantification | Aidoc Medical Ltd. | 3 |
| OrthoNext™ Platform System Software | Orthofix SRL | 3 |
| MI View&GO | Siemens Medical Solutions USA, Inc. | 3 |
| FEops | Feops NV | 3 |
| AI-Rad Companion Brain MR | Siemens Healthcare Limited | 3 |
Showing 12 of 147. All products under Automated Radiological Image Processing Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261349 | 2026-07-24 |
| K253775 | 2026-03-26 |
| K251483 | 2025-09-23 |
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.