Clearance Summary
QUANTIVA received FDA 510(k) clearance under submission number K061418, sponsored by Tomographix IP , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-07-21.
- Submission: K061418
- Applicant / Sponsor: Tomographix IP , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2006-07-21
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.