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510(k) K203845

Philips IntelliSite Pathology Solution by Philips Medical Systems Nederland B.V. — Product Code PSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2021
Date Received
December 31, 2020
Clearance Type
Abbreviated
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).

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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)