Class Class II
Precision DL (K223212)
Description
Precision DL by Ge Healthcare, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223212
Clearance Date2023-04-27
Clearance TypeTraditional
Product CodeKPS
Regulation Number892.1200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223212
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. Precision DL (K223212) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221932 | Omni Legend | GE Healthcare | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233660 | nCommand Lite System | Ionic Health | 2024 |
Trace the full predicate network for K223212
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.