Class Class II
Cyware 4H and Cysart 4H (K221796)
Description
Cyware 4H and Cysart 4H by Abys Medical, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221796
Clearance Date2022-12-30
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221796
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. Cyware 4H and Cysart 4H (K221796) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210072 | HOLOSCOPE-i | Real View Imaging , Ltd. | 2021 |
| K203195 | Simpleware ScanIP Medical | Synopsys (Northern Europe) , Ltd. | 2021 |
| K172418 | OpenSight | Novarad Corporation | 2018 |
| K171754 | NovaPACS | Novarad Corporation | 2017 |
| K141669 | SURGIMAP | Nemaris, Inc. | 2014 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243069 | LUMYS (V1) | Intradys | 2025 |
Trace the full predicate network for K221796
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.