# K133719: Pde-Neo

- Pathway: 510(k) (Traditional)
- Applicant: Hamamatsu Photonics K.K.
- Decided: Mar 27, 2014 after 112 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944261 (1994). 11 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110480: Pde Photodynamic Eye, Hamamatsu Photonics K.K. (2012)

## Most influential descendants
- 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
- K230727: SPY Portable Handheld Imaging (SPY-PHI) System (2023), 4 descendants of its own

## Indications for use
The Pde-neo 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/K133719
Methodology: https://510kreport.com/methodology