# K110480: Pde Photodynamic Eye

- Pathway: 510(k) (Traditional)
- Applicant: Hamamatsu Photonics K.K.
- Decided: Jan 13, 2012 after 329 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
Longest line of descent: 6 generations back to K944261 (1994). 10 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063345: Spy Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.
- K073130: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K133719: Pde-Neo (2014), 11 descendants of its own
- K162885: SPY Phi Open Field Handheld Fluorescence Imaging System (2017), 10 descendants of its own
- 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

## Indications for use
The PDE is an imaging system used in capturing and viewing fluorescent 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 during plastic, micro-, reconstructive and organ transplant surgeries.

Source page: https://510kreport.com/device/K110480
Methodology: https://510kreport.com/methodology