Clearance Summary
Koios DS for Breast received FDA 510(k) clearance under submission number K190442, sponsored by Koios Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-07-03.
- Submission: K190442
- Applicant / Sponsor: Koios Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2060
- Decision date: 2019-07-03
Classification & Regulation
This clearance is catalogued under FDA product code POK and 21 CFR 892.2060, within the Radiology review panel as a Class II device.