FDA-cleared K233030
BoneMRI
MRIguidance B.V
MRI-processing software that creates an added bone-contrast image series for review beside the original scan.
- Modality
- MRI
- Anatomy
- Spine
- Decision
- 2024-03-01
Vendor
MRIguidance B.V
3 FDA submission entries in this directory. This is not a count of distinct commercial offers.
Claim vendor profileTurn this list into an evaluation
Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.
- Which exact product, version and licensed modules are in the current offer?
- Do related FDA submissions document the same scope, or different functions and versions?
- Which costs, support obligations and local acceptance tests remain unresolved?
Prepare with a buyer guide:
Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families
FDA-cleared K230197
BoneMRI v1.6
MRIguidance B.V.
Authorized purpose: 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 replacement.
- Modality
- MRI
- Anatomy
- Spine
- Decision
- 2023-02-22
FDA-cleared K202404
BoneMRI
MRIguidance B.V
Authorized purpose: 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 does not replace CT.
- Modality
- MRI
- Anatomy
- Pelvic sacrum, hip bones, and femoral heads
- Decision
- 2021-12-22