SPY Portable Handheld Imaging (SPY-PHI) System— 510(k) K230727
Substantially EquivalentNovadaq 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).
Clearance details
- Applicant
- Novadaq Technologies Ulc (A Part of Stryker)
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnaby, CA
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
Source: openFDA MAUDE database, through . 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.