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FDA 510(k)

SPY-PHI System with SPY-PHI Fluorescence Assessment Software

K-Number: K202244 · 2020-11-05

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker)
Decision Date2020-11-05
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPY-PHI System with SPY-PHI Fluorescence Assessment Software is a medical device manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2020-11-05 under approval number K202244. 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 System with SPY-PHI Fluorescence Assessment Software?

SPY-PHI System with SPY-PHI Fluorescence Assessment Software is a medical device that received FDA 510(k) clearance on 2020-11-05. It is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K202244.

When was SPY-PHI System with SPY-PHI Fluorescence Assessment Software approved by the FDA?

SPY-PHI System with SPY-PHI Fluorescence Assessment Software received FDA 510(k) clearance on 2020-11-05, under approval number K202244.

What company makes SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

SPY-PHI System with SPY-PHI Fluorescence Assessment Software is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker).

What is the FDA product code for SPY-PHI System with SPY-PHI Fluorescence Assessment Software?

The FDA product code for SPY-PHI System with SPY-PHI Fluorescence Assessment Software is OWN.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026) 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)

Other Devices by Novadaq Technologies Ulc. (Now A Part of Stryker)

K182606PINPOINT Endoscopic Fluorescence Imaging System K192174SPY Portable Handheld Imaging (SPY-PHI) System K190729SPY Portable Handheld Imaging (SPY-PHI) System K182907SPY Elite Intraoperative Perfusion Assessment System K200737SPY Portable Handheld Imaging (SPY-PHI) 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.

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