Class Class II
Vitrea Software Package, VSTP-002A (K223336)
Description
Vitrea Software Package, VSTP-002A by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223336
Clearance Date2023-01-09
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223336
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. Vitrea Software Package, VSTP-002A (K223336) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging Syst... | Canon Medical Systems Corporation | 2022 |
| K161322 | CT CoPilot | Zepmed, LLC | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240705 | Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation | 2024 |
Trace the full predicate network for K223336
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.