SyMRI 10
SyMRI 10 is a Class II device made by SyntheticMR AB (publ), cleared under FDA 510(k) K242524 on 6 Dec 2024 (2 earlier submissions) and listed in FDA GUDID since 10 Jan 2018 (UDI-DI 07340024700023), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) 510(k) | NumberK242524 | Date6 Dec 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07340024700023 | Date10 Jan 2018 | StatusListed |
| United States | FDA 510(k) GUDID | NumberK162943 | Date29 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 07340024700023
- FDA 510(k) database K242524
- FDA 510(k) database K233733
- FDA 510(k) database K162943
Across registries
- FDA 510(k) K242524 decided 6 Dec 2024 Active
- FDA GUDID UDI-DI 07340024700023 listed 10 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K162943
- Listed FDA GUDID 07340024700023
- Cleared FDA 510(k) K233733
- Cleared FDA 510(k) K242524
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SyMRI
- Generic name
- MRI system application software
- Model / reference
- 10
- Primary DI / UDI-DI
- 07340024700023
- 510(k) Number
- FDA product code
- LNH
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.1000
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under MRI system application software.