Cleared Traditional

SPY Portable Handheld Imaging (SPY-PHI) System

K230727 · Novadaq Technologies Ulc (A Part of Stryker) · General & Plastic Surgery

Jun 2023

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K230727 is an FDA 510(k) clearance for the SPY Portable Handheld Imaging (SPY-PHI) System, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Novadaq Technologies Ulc (A Part of Stryker) (Burnaby, CA). The FDA issued a Cleared decision on June 5, 2023, 81 days after receiving the submission on March 16, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number	K230727 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 2023
Decision Date	June 05, 2023
Days to Decision	81 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF