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FDA 510(k)

SPY Portable Handheld Imaging (SPY-PHI) System

K-Number: K200737 · 2020-05-21

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker)
Decision Date2020-05-21
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPY Portable Handheld Imaging (SPY-PHI) System is a medical device manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2020-05-21 under approval number K200737. 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 Portable Handheld Imaging (SPY-PHI) System?

SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2020-05-21. It is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K200737.

When was SPY Portable Handheld Imaging (SPY-PHI) System approved by the FDA?

SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2020-05-21, under approval number K200737.

What company makes SPY Portable Handheld Imaging (SPY-PHI) System?

SPY Portable Handheld Imaging (SPY-PHI) System is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker).

What is the FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System?

The FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System is OWN.

Related Clinical Trials

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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: 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) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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 K202244SPY-PHI System with SPY-PHI Fluorescence Assessment Software

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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