Class Class II
SpectraWAVE Imaging System (K221257)
Description
SpectraWAVE Imaging System by Spectrawave, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221257
Clearance Date2023-02-28
Clearance TypeTraditional
Product CodeNQQ
Regulation Number892.1560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221257
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. SpectraWAVE Imaging System (K221257) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software versi... | ABBOTT MEDICAL | 2019 |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Im... | Infraredx, Inc. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | 2025 |
| K230691 | HyperVue Imaging System | Spectrawave, Inc. | 2023 |
Trace the full predicate network for K221257
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.