Clearance Summary
Bindex BI-2 received FDA 510(k) clearance under submission number K161971, sponsored by Bone Index Finland , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-01-09.
- Submission: K161971
- Applicant / Sponsor: Bone Index Finland , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1180
- Decision date: 2017-01-09
Classification & Regulation
This clearance is catalogued under FDA product code MUA and 21 CFR 892.1180, within the Radiology review panel as a Class II device.