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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 the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2019-01-23 under 510(k) 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. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K182907.

When did SPY Elite Intraoperative Perfusion Assessment System receive FDA 510(k) clearance?

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

Who is the listed applicant for SPY Elite Intraoperative Perfusion Assessment System?

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

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.

Other records listing Novadaq Technologies Ulc. (Now A Part of Stryker) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareK200737SPY Portable Handheld Imaging (SPY-PHI) SystemK192174SPY Portable Handheld Imaging (SPY-PHI) SystemK190729SPY Portable Handheld Imaging (SPY-PHI) SystemK182606PINPOINT Endoscopic Fluorescence Imaging System

Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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