SPY Portable Handheld Imaging (SPY-PHI) System (K230727)
Description
SPY Portable Handheld Imaging (SPY-PHI) System by Novadaq Technologies Ulc (A Part of Stryker), an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230727
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. SPY Portable Handheld Imaging (SPY-PHI) System (K230727) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Pa... | 2020 |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Pa... | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026 |
Trace the full predicate network for K230727
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.