Class Class II
BoneMRI v1.6 (K230197)
Description
BoneMRI v1.6 by Mriguidance B.V., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230197
Clearance Date2023-02-22
Clearance TypeSpecial
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230197
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BoneMRI v1.6 (K230197) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221762 | BoneMRI v1.4 | Mrlguidance B.V. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233030 | BoneMRI | Mriguidance B.V. | 2024 |
Trace the full predicate network for K230197
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.