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FDA 510(k)

SPY Portable Handheld Imaging (SPY-PHI) System

K-Number: K192174 · 2019-11-15

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker)
Decision Date2019-11-15
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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. (Now A Part of Stryker). It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K192174. 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 2019-11-15. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K192174.

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 2019-11-15, under 510(k) number K192174.

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

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

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) SystemK190729SPY Portable Handheld Imaging (SPY-PHI) SystemK182907SPY Elite Intraoperative Perfusion Assessment SystemK182606PINPOINT Endoscopic Fluorescence Imaging System

Related Devices (Code: OWN)

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.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

Official Source

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