Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPY Phi Open Field Handheld Fluorescence Imaging System

K-Number: K162885 · 2017-01-11

ApplicantNovadaq Technologies, Inc.
Decision Date2017-01-11
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPY Phi Open Field Handheld Fluorescence Imaging System is a medical device manufactured by Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2017-01-11 under approval number K162885. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPY Phi Open Field Handheld Fluorescence Imaging System?

SPY Phi Open Field Handheld Fluorescence Imaging System is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Novadaq Technologies, Inc.. The 510(k) number is K162885.

When was SPY Phi Open Field Handheld Fluorescence Imaging System approved by the FDA?

SPY Phi Open Field Handheld Fluorescence Imaging System received FDA 510(k) clearance on 2017-01-11, under approval number K162885.

What company makes SPY Phi Open Field Handheld Fluorescence Imaging System?

SPY Phi Open Field Handheld Fluorescence Imaging System is manufactured by Novadaq Technologies, Inc..

What is the FDA product code for SPY Phi Open Field Handheld Fluorescence Imaging System?

The FDA product code for SPY Phi Open Field Handheld Fluorescence Imaging System is OWN.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06561828 Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41839210 Artificial Intelligence in Radiology: Unlocking New Dimensions of Value. RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Novadaq Technologies, Inc.

K161792PINPOINT Endoscopic Fluorescence Imaging System K150956PINPOINT Endoscopic Fluorescence Imaging System

Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑