Clearance Summary
Fine Structure Analysis(fineSA) received FDA 510(k) clearance under submission number K150069, sponsored by Acuitas Medical , 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 2015-05-22.
- Submission: K150069
- Applicant / Sponsor: Acuitas Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2015-05-22
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.