SwiftMR A20-CL
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- SwiftMR EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- SwiftMR EUDAMEDSwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices. FDA UDI
- Model / Reference
- A20-CL EUDAMEDA20-CL v3.0.X.X(v1.3.4.X(US)) FDA UDI
- Description
- SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images. SwiftMR is not intended for use on mobile devices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800124700099 EUDAMEDFDA UDI
- Basic UDI-DI
- 88001247SWIFTMRYN EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The SwiftMR is an AI-powered MRI reconstruction system (Nomenclature Code: Z11030592) designed to enhance MRI image quality and reduce scan times. It employs deep-learning algorithms to process raw MRI data, improving signal-to-noise ratio (SNR) and resolution while maintaining compatibility across different body parts and MRI vendors. This Class IIa device operates in a vendor-neutral manner, integrating seamlessly with existing MRI systems without requiring hardware modifications.
SwiftMR is supplied as a non-sterile, non-reusable, active medical device (Reference: A20-CL) and operates within the DICOM format for compatibility. It is intended for use in radiology settings and has received FDA 510K clearance and MDR authorization. The device is not implantable, latex-free, or reprocessed, and its performance is validated for use with standard MRI systems. Storage and handling follow general medical device protocols, as specified by the manufacturer.
Frequently asked questions
What is the primary purpose of the SwiftMR system in an MRI workflow and how does it improve imaging outcomes?
The SwiftMR is designed to enhance MRI image quality and reduce scan times by using AI-powered deep-learning algorithms to process raw MRI data. It improves the signal-to-noise ratio (SNR) and resolution, ensuring clearer images across different body parts and MRI vendors without requiring hardware modifications to existing systems.
Is the SwiftMR system reusable or single-use, and what does this mean for its maintenance and usage in a clinical setting?
The SwiftMR is a non-reusable, non-sterile device, meaning it is intended for single-use only. Clinically, this simplifies handling and reduces the need for reprocessing or sterilization, but it requires replacement after each use. Storage and handling follow standard medical device protocols as outlined by the manufacturer.
How does the SwiftMR integrate with existing MRI systems, and what compatibility considerations should clinicians keep in mind?
The SwiftMR operates in a vendor-neutral manner and integrates seamlessly with existing MRI systems without requiring hardware changes. It uses the DICOM format for compatibility, ensuring it works across different MRI vendors and body parts. Clinicians should confirm their specific MRI system’s compatibility with the manufacturer’s guidelines.
What regulatory approvals does the SwiftMR hold, and how does this affect its availability in different markets?
The SwiftMR has received FDA 510(k) clearance and MDR authorization, confirming its compliance with U.S. and European Union regulatory standards. These approvals validate its safety and effectiveness for use in radiology settings, supporting its availability in markets where these regulatory pathways apply.
Does the SwiftMR require any special storage conditions, and what should be considered when handling it in a clinical environment?
The SwiftMR follows general medical device storage and handling protocols, as specified by the manufacturer. Since it is non-sterile and non-reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. No special sterilization or reprocessing is required, but proper inventory management is needed due to its single-use nature.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SwiftMR® AI MRI Reconstruction and Scan-Time Reduction | AIRS Medical, AIRS Medical | AI-Powered MRI Reconstruction and Quantitative Imaging, AIRS Medical, SwiftMR - AIRS Medical - Health AI Register
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253775 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K230854 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220416 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K210999 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88001247SWIFTMRYN | Class IIa | Active |
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Manufacturer
- Manufacturer
- AIRS Medical Inc.
- EUDAMED SRN
- KR-MF-000009149
- FDA Applicant
- Airs Medical, Inc.
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED e8b2ce31-da84-4fc2-ab27-02d0735a27e6 85 fields · synced Oct 6, 2026
- FDA UDI 2cfd0747-f7ed-427c-83b6-a74e39084dea 34 fields · synced May 30, 2026
- FDA 510(k) K253775 1 fields · synced May 18, 2026