Aperio iQC DX Software— 510(k) K253561
Substantially EquivalentLeica Biosystems Imaging, Inc.
FDA 510(k) clearance K253561 for Aperio iQC DX Software, Substantially Equivalent on 2026-08-07. Applicant: Leica Biosystems Imaging, Inc.. Device class: 2.
Summary
Leica Biosystems Imaging filed Aperio iQC DX Software under product code SIX, digital pathology image artifact detection software devices. The record has no description beyond the name and that code name.
Class II, 21 CFR 864.3700. Pathology is both the classification panel and the review panel. It was a Traditional 510(k).
Leica filed from Vista, California. The substantially equivalent decision came 263 calendar days after receipt (November 17, 2025 to August 7, 2026).
Clearance details
- Applicant
- Leica Biosystems Imaging, Inc.
- Product code
- Product code SIX
- 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
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