FDA 510(k)

SPY Portable Handheld Imaging (SPY-PHI) System

Numéro K : K230727 · 2023-06-05

DemandeurNovadaq Technologies Ulc (A Part of Stryker)

Date de décision2023-06-05

Code produitIZI

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

SPY Portable Handheld Imaging (SPY-PHI) System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies Ulc (A Part of Stryker). It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K230727. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Novadaq Technologies Ulc (A Part of Stryker). The 510(k) number is K230727.

When did SPY Portable Handheld Imaging (SPY-PHI) System receive FDA 510(k) clearance?

SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2023-06-05, under 510(k) number K230727.

Who is the listed applicant for SPY Portable Handheld Imaging (SPY-PHI) System?

The FDA 510(k) record lists Novadaq Technologies Ulc (A Part of Stryker) as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : IZI)

K261037Système d'imagerie portable mains-libres SPY-PHI à 780 nmStryker Endoscopy K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

Source officielle

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