Identity
- Trade Name
- SyMRI FDA UDI
- Generic Name
- MRI system application software FDA UDI
- Device Name
- SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME images. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). FDA UDI
- Model / Reference
- 11 FDA UDI
- Description
- SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME images. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07340024700030 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- MRI system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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Implantable
No
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Contains Latex
No
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Prescription Use
No
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
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Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
No
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Serial Number
Yes
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: MRI system application software
SyMRI by SyntheticMR AB (publ) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SyntheticMR AB (publ)
Sources (1)
- FDA UDI 04c739fb-a81b-4ce5-9ffc-66796ca4f003 34 fields · synced May 30, 2026