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510(k) K232202

Aperio GT 450 DX by Leica Biosystems Imaging, Inc. — Product Code PSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2024
Date Received
July 25, 2023
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.

  • K190332 — Aperio AT2 DX System (May 20, 2019)
  • K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEM (July 29, 2014)

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  • K242848 — Philips IntelliSite Pathology Solution 5.1 (December 10, 2024)
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  • K233204 — Philips IntelliSite Pathology Solution 5.1 (June 24, 2024)
  • K232879 — Roche Digital Pathology Dx (VENTANA DP 200) (June 14, 2024)
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