Class Class II
AccuICAS (K221711)
Description
AccuICAS by ArteryFlow Technology Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221711
Clearance Date2023-02-28
Clearance TypeTraditional
Product CodeQHA
Regulation Number892.1600
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221711
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. AccuICAS (K221711) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021 |
Trace the full predicate network for K221711
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.