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FDA 510(k)

SPY Elite Intraoperative Perfusion Assessment System

K-Number: K182907 · 2019-01-23

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker)
Decision Date2019-01-23
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPY Elite Intraoperative Perfusion Assessment System is a medical device manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2019-01-23 under approval number K182907. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPY Elite Intraoperative Perfusion Assessment System?

SPY Elite Intraoperative Perfusion Assessment System is a medical device that received FDA 510(k) clearance on 2019-01-23. It is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K182907.

When was SPY Elite Intraoperative Perfusion Assessment System approved by the FDA?

SPY Elite Intraoperative Perfusion Assessment System received FDA 510(k) clearance on 2019-01-23, under approval number K182907.

What company makes SPY Elite Intraoperative Perfusion Assessment System?

SPY Elite Intraoperative Perfusion Assessment System is manufactured by Novadaq Technologies Ulc. (Now A Part of Stryker).

What is the FDA product code for SPY Elite Intraoperative Perfusion Assessment System?

The FDA product code for SPY Elite Intraoperative Perfusion Assessment System is IZI.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (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) PMID: 41524152 Securing data management systems in perfusion: A narrative review on cybersecurity and clinical risk. Perfusion (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (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 K202244SPY-PHI System with SPY-PHI Fluorescence Assessment Software K200737SPY Portable Handheld Imaging (SPY-PHI) System

Related Devices (Code: IZI)

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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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