SPY Phi Open Field Handheld Fluorescence Imaging System— 510(k) K162885

Substantially Equivalent

Novadaq Technologies, Inc.

FDA 510(k) clearance K162885 for SPY Phi Open Field Handheld Fluorescence Imaging System, Substantially Equivalent on 2017-01-11. Applicant: Novadaq Technologies, Inc..

Clearance details

Applicant: Novadaq Technologies, Inc.
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2016-10-17
Decision date: 2017-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.