Leica Biosystems Imaging, Inc. is one of 16294 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Leica Biosystems Imaging, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Aperio GT 450 DX, Aperio iQC DX Software, Aperio GT 450 DX
5
Total
5
Cleared
0
Denied
Leica Biosystems Imaging, Inc. has 5 FDA 510(k) cleared medical devices. Based in Vista, US.
Latest FDA clearance: Aug 2026. Active since 2014. Primary specialty: Pathology.
Browse the FDA 510(k) cleared devices submitted by Leica Biosystems Imaging, Inc. Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Leica Biosystems Imaging, Inc.
5 devices