Clearance Summary
Annalise Enterprise received FDA 510(k) clearance under submission number K253818, sponsored by Harrison-AI Medical Pty, 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 2026-03-03.
- Submission: K253818
- Applicant / Sponsor: Harrison-AI Medical Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2080
- Decision date: 2026-03-03
Classification & Regulation
This clearance is catalogued under FDA product code QAS and 21 CFR 892.2080, within the Radiology review panel as a Class II device.