Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPY Portable Handheld Imaging (SPY-PHI) System

K-Number: K200737 · 2020-05-21

ApplicantNovadaq Technologies Ulc. (Now A Part of Stryker)
Decision Date2020-05-21
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 2020-05-21 under 510(k) number K200737. 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 2020-05-21. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K200737.

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 2020-05-21, under 510(k) number K200737.

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 SoftwareK192174SPY 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

View on FDA Database →

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

↑