Class Class II
VersaViewer (K243651)
Description
VersaViewer by GE Medical Systems SCS, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243651
Clearance Date2025-04-21
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243651
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. VersaViewer (K243651) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233714 | BreView | GE Medical Systems SCS | 2024 |
| K081985 | AW SERVER | Ge Medical Systems, LLC | 2008 |
| K041521 | VOLUME VIEWER PLUS | General Electric Medical Systems | 2004 |
Trace the full predicate network for K243651
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.