Clearance Summary
FullFocus received FDA 510(k) clearance under submission number K201005, sponsored by Paige.Ai, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2020-07-15.
- Submission: K201005
- Applicant / Sponsor: Paige.Ai, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2020-07-15
Classification & Regulation
This clearance is catalogued under FDA product code QKQ and 21 CFR 864.3700, within the Pathology review panel as a Class II device.