# K162885: SPY Phi Open Field Handheld Fluorescence Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Jan 11, 2017 after 86 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K944261 (1994). 25 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133719: Pde-Neo, Hamamatsu Photonics K.K. (2014) Summary page 6.
- K132475: Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System, Fluoptics (2014) Summary page 6.
- K063345: Spy Imaging System, Novadaq Technologies, Inc. (2007) Summary page 4.
- K100371: Spy Intra-Operative Imaging System, Novadaq Technologies, Inc. (2011) Summary page 4.

## 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

## Recalls of this device
- Jan 7, 2020 · Class II · Z-1925-2020: Sterile drapes packaged in an unsealed pouch.

## Indications for use
The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The SPY Phi Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures.

Source page: https://510kreport.com/device/K162885
Methodology: https://510kreport.com/methodology