Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K234009)
Description
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) by Mighty Oak Medical, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234009
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. Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K234009) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183489 | D2P | 3D Systems, Inc. | 2019 |
| K183105 | Mimics Medical | Materialise NV | 2019 |
Trace the full predicate network for K234009
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.