Clearance Summary
Aperio GT 450 DX; Aperio GT 180 DX received FDA 510(k) clearance under submission number K253554, sponsored by Leica Biosystems Imaging, 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 2026-08-07.
- Submission: K253554
- Applicant / Sponsor: Leica Biosystems Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2026-08-07
Classification & Regulation
This clearance is catalogued under FDA product code PSY and 21 CFR 864.3700, within the Pathology review panel as a Class II device.