Cleared Traditional

K230727 - SPY Portable Handheld Imaging (SPY-PHI) System (FDA 510(k) Clearance)

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

Jun 2023

Decision

81d

Days

Class 2

Risk

K230727 is an FDA 510(k) clearance for the SPY Portable Handheld Imaging (SPY-PHI) System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number	K230727 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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