Clearance Summary
SPY ANALYSIS TOOLKIT, MODEL SA9000 received FDA 510(k) clearance under submission number K081792, sponsored by Novadaq Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-09-17.
- Submission: K081792
- Applicant / Sponsor: Novadaq Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2008-09-17
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.