# K190729: SPY Portable Handheld Imaging (SPY-PHI) System

- Pathway: 510(k) (Special)
- Applicant: Novadaq Technologies Ulc. (Now A Part of Stryker)
- Decided: Apr 19, 2019 after 29 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K192174: SPY Portable Handheld Imaging (SPY-PHI) System (2019), 9 descendants of its own
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (2020), 8 descendants of its own
- K202244: SPY-PHI System with SPY-PHI Fluorescence Assessment Software (2020), 5 descendants of its own
- K230727: SPY Portable Handheld Imaging (SPY-PHI) System (2023), 4 descendants of its own
- K261037: 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K190729
Methodology: https://510kreport.com/methodology