Clearance Summary
SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance under submission number K230727, sponsored by Novadaq Technologies Ulc (A Part of Stryker). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-06-05.
- Submission: K230727
- Applicant / Sponsor: Novadaq Technologies Ulc (A Part of Stryker)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 2023-06-05
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.