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FDA-cleared K223442

MR 5300 and MR 7700 R11 MR Systems

Philips Medical Systems Nederlands B.V.

Authorized purpose: The MR 5300 and MR 7700 R11 systems produce cross-sectional MR images, spectra, and derived parameters of the head, body, and extremities for interpretation by trained physicians and support labeled interventional MR-fluoroscopy workflows with compatible instruments selected and evaluated by the clinical user.

Modality
MRI
Anatomy
Multi-region
Decision
2022-12-23