FDA-cleared K233030

BoneMRI

MRIguidance B.V

MRI-based BoneMRI image enhancement for visualizing pelvic and cervical, thoracic, lumbar and S1 spinal bone structures with CT-like radiodensity contrast; not for tumor diagnosis...

Modality
MRI
Anatomy
Spine
Decision
2024-03-01
FDA-cleared K230197

BoneMRI v1.6

MRIguidance B.V.

MRI-based BoneMRI v1.6 image enhancement for visualizing pelvic and L3-S1 lumbar bone structures with enhanced contrast; not for tumor diagnosis or monitoring and not a CT...

Modality
MRI
Anatomy
Spine
Decision
2023-02-22
FDA-cleared K202404

BoneMRI

MRIguidance B.V

BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and...

Modality
MRI
Anatomy
Pelvic sacrum, hip bones, and femoral heads
Decision
2021-12-22