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510(k) K190332

Aperio AT2 DX System by Leica Biosystems Imaging, Inc. — Product Code PSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2019
Date Received
February 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Slide Imaging System
Device Class
Class II
Regulation Number
864.3700
Review Panel
PA
Submission Type

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. The system generates digital images that would otherwise be appropriate for manual visualization by conventional brightfield microscopy. The whole slide imaging system is not intended for use with slides prepared from frozen tissue, cytology, and non-FFPE hematopathology specimens (e.g., peripheral blood smear).

Other clearances by Leica Biosystems Imaging, Inc.

  • K232202 — Aperio GT 450 DX (April 16, 2024)
  • K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEM (July 29, 2014)

Other clearances for product code PSY

  • K243871 — Philips IntelliSite Pathology Solution 5.1 (March 6, 2025)
  • K241717 — E1000 Dx Digital Pathology Solution (February 28, 2025)
  • K242783 — Roche Digital Pathology Dx (December 17, 2024)
  • K242848 — Philips IntelliSite Pathology Solution 5.1 (December 10, 2024)
  • K241871 — Philips IntelliSite Pathology Solution (December 2, 2024)
  • K233204 — Philips IntelliSite Pathology Solution 5.1 (June 24, 2024)
  • K232879 — Roche Digital Pathology Dx (VENTANA DP 200) (June 14, 2024)
  • K232833 — HALO AP Dx (May 7, 2024)
  • K232202 — Aperio GT 450 DX (April 16, 2024)
  • K232208 — Sectra Digital Pathology Module (Version 3.3) (April 16, 2024)