Home / 510(k) Clearances / K233027

510(k) K233027

NanoZoomer S360MD Slide scanner system by Hamamatsu Photonics K.K. — Product Code PSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
September 25, 2023
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).

Other clearances by Hamamatsu Photonics K.K.

  • K213883 — NanoZoomer S360MD Slide scanner system (September 27, 2022)
  • K162117 — NIRO-200NX DP (October 25, 2016)
  • K143219 — NIRO-200NX (July 31, 2015)
  • K133719 — PDE-NEO (March 27, 2014)
  • K110480 — PDE PHOTODYNAMIC EYE (January 13, 2012)
  • K982171 — HAMAMATSU PET SCANNER, MODEL SHR-22000 (September 17, 1998)
  • K896331 — V2465P X-RAY IMAGE INTENSIFIER (December 22, 1989)

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)