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FDA 510(k)

SPY Portable Handheld Imaging (SPY-PHI) System

K-Number: K230727 · 2023-06-05

ApplicantNovadaq Technologies Ulc (A Part of Stryker)
Decision Date2023-06-05
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPY Portable Handheld Imaging (SPY-PHI) System is a medical device manufactured by Novadaq Technologies Ulc (A Part of Stryker). It received FDA 510(k) clearance on 2023-06-05 under approval number K230727. 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 Portable Handheld Imaging (SPY-PHI) System?

SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by Novadaq Technologies Ulc (A Part of Stryker). The 510(k) number is K230727.

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 2023-06-05, under approval number K230727.

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

SPY Portable Handheld Imaging (SPY-PHI) System is manufactured by Novadaq Technologies Ulc (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 IZI.

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Related PubMed Literature

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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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