Clearance Summary
Bindex BI-2 received FDA 510(k) clearance under submission number K211350, sponsored by Bone Index Finland , 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 2022-04-29.
- Submission: K211350
- Applicant / Sponsor: Bone Index Finland , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1180
- Decision date: 2022-04-29
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.