Table 2.
Fluorescence imaging system | Company | Year approved/510(k) cleared | FDA 510(k) number | Predicate device(s) |
---|---|---|---|---|
SPY Intra-operative Imaging System | Novadaq Technologies Inc. | 2005 | K042961 | The Philips Integra Series 2 Systems (K984545) Heidelberg Retinal Angiographic System (K944261) |
PDE Fluorescent Angiographic system | Hamamatsu Photonics K.K. | 2012 | K110480 | Novadaq Technologies Inc.’s SPY Imaging System SP2000 (K063345) SPY Fluorescent Imaging System SP2001 (K073130) |
Fluobeam 800 Clinic Imaging Device | Fluoptics | 2014 | K132475 | Hamamatsu Photonics K.K., PDE Fluorescent Angiographic System (K133719) |
da Vinci Firefly Imaging System | Intuitive Surgical | 2014 | K141077 | da Vinci Xi Surgical System device (K131861) da Vinci Fluorescence Imaging Vision System (K101077) |
The Artemis Handheld Imaging System | Quest Medical Imaging | 2015 | K143474 | PDE of Hamamatsu (K110480) Fluobeam of Fluoptics (K132475) |
VS3-IR-MMS System | VisionSense Ltd | 2015 | K150018 | Novadaq Technologies SPY Imaging System (K063345) |
PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Inc. | 2016 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System (K150956) |