FDA.reportPublic FDA data

510(k) K241717

Device
E1000 Dx Digital Pathology Solution
Applicant
Shandon Diagnostics Limited
510(k) number
K241717
Product code
PSY
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-28
Date received
2024-06-14
Regulation
864.3700
Classification name
Whole Slide Imaging System
Medical specialty
Pathology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Naveen Kaki
Address
Tudor Rd., Manor Park, Cheshire Runcorn GB WA7 1TA WA7 1TA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PSY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.2025-03-06
K242783Roche Digital Pathology DxVentana Medical Systems, Inc.2024-12-17
K242848Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.2024-12-10
K241871Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.2024-12-02
K233204Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.2024-06-24
K232879Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc.2024-06-14
K232833HALO AP DxIndica Labs, Inc.2024-05-07
K232208Sectra Digital Pathology Module (Version 3.3)Sectra AB2024-04-16
K232202Aperio GT 450 DXLeica Biosystems Imaging, Inc.2024-04-16
K230839Concentriq DxProscia, Inc.2024-02-08
K233027NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.2023-12-22
K213883NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.2022-09-27
K203845Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.2021-09-17
K203364MDPC-8127Barco N.V.2021-04-15
K192259Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V.2019-09-20