Clearance Summary
SPY Elite Intraoperative Perfusion Assessment System received FDA 510(k) clearance under submission number K182907, sponsored by Novadaq Technologies Ulc. (Now 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 2019-01-23.
- Submission: K182907
- Applicant / Sponsor: Novadaq Technologies Ulc. (Now A Part of Stryker)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 2019-01-23
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.