Clearance Summary
ULTRASOUND SCANNER FLEX FOCUS received FDA 510(k) clearance under submission number K123254, sponsored by B-K Medical Aps. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-02-13.
- Submission: K123254
- Applicant / Sponsor: B-K Medical Aps
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2013-02-13
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.