Aperio GT 450 DX; Aperio GT 180 DX— 510(k) K253554
Substantially EquivalentLeica Biosystems Imaging, Inc.
FDA 510(k) clearance K253554 for Aperio GT 450 DX; Aperio GT 180 DX, Substantially Equivalent on 2026-08-07. Applicant: Leica Biosystems Imaging, Inc.. Device class: 2.
Summary
Leica Biosystems Imaging's submission lists the Aperio GT 450 DX and the Aperio GT 180 DX. They're filed under product code PSY, whole slide imaging systems.
Class II, 21 CFR 864.3700. Pathology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Leica filed from Vista, California. The decision came 266 calendar days after FDA received it (November 14, 2025 to August 7, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Leica Biosystems Imaging, Inc.
- Product code
- Product code PSY
- Device class
- Class 2
- Regulation
- 21 CFR 864.3700
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vista, CA, US
Recent devices under product code PSY
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