Class Class I
3D-RD-S (K212587)
Description
3D-RD-S by Radiopharmaceutical Imaging and Dosimetry, LLC, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK212587
Clearance Date2023-02-22
Clearance TypeTraditional
Product CodeIYX
Regulation Number892.1100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K212587
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. 3D-RD-S (K212587) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K163687 | OLINDA EXM | Hermes Medical Solutions AB | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231047 | UniSyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions | 2023 |
Trace the full predicate network for K212587
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.