MR 5300 and MR 7700 R11 MR Systems

510(k) K223442

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK223442	Date23 Dec 2022Cleared	StatusActive

5 recalls · 5 ongoing · FDA

- Ongoing Z-3312-2026 FDA Class II initiated 28 Aug 2026
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
- Ongoing Z-3241-2026 FDA Class II initiated 21 Aug 2026
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
- Ongoing Z-1214-2026 FDA Class II initiated 3 Dec 2025
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Ongoing Z-2213-2025 FDA Class II initiated 30 Jun 2025
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Ongoing Z-1804-2025 FDA Class II initiated 13 May 2025
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

1 jurisdiction

United States — FDA 510(k) Active

510(k)