510(k) K253561
- Device
- Aperio iQC DX Software
- Applicant
- Leica Biosystems Imaging, Inc.
- 510(k) number
- K253561
- Product code
- SIX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-07
- Date received
- 2025-11-17
- Regulation
- 864.3700
- Classification name
- Digital Pathology Image Artifact Detection Software Device
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tamatha Melton
- Address
- 1360 Park Center Dr. Vista CA US 92081 92081