Clearance Summary
Fusion Bx 2.0 received FDA 510(k) clearance under submission number K181290, sponsored by Focal Healthcare, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-06-15.
- Submission: K181290
- Applicant / Sponsor: Focal Healthcare, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2018-06-15
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.