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. Author manuscript; available in PMC: 2018 May 1.
Published in final edited form as: Cancer Res. 2017 Apr 20;77(9):2197–2206. doi: 10.1158/0008-5472.CAN-16-3217

Table 2.

Tabular overview detailing the currently 510(k) cleared devices

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)