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

Name: FDA 510(k) clearance K230727
Creator: U.S. Food and Drug Administration
Published: 2023-06-05

Substantially Equivalent

Novadaq Technologies Ulc (A Part of Stryker)

FDA 510(k) clearance K230727 for SPY Portable Handheld Imaging (SPY-PHI) System, Substantially Equivalent on 2023-06-05. Applicant: Novadaq Technologies Ulc (A Part of Stryker). Device class: 2.

Clearance details

Applicant: Novadaq Technologies Ulc (A Part of Stryker)
Product code: Code IZI
Device class: Class 2
Regulation: 21 CFR 892.1600
Advisory panel: Radiology
Date received: 2023-03-16
Decision date: 2023-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZI

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K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System2026-05-28
K253181 — SURGIMAGE SIM 1000H Fluorescence Imaging Platform2026-05-13
K243645 — IC-Flow Imaging System 2.02025-09-22
K243077 — Affirm 8002025-06-27
K231986 — Modus IR2024-03-25

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.