Philips IntelliSite Pathology Solution 5.1
Philips Medical Systems Nederland B.V.The Philips IntelliSite Pathology Solution 5.1 is an automated system that creates, views, and manages digital images of pathology slides prepared from tissue samples. It aids pathologists by providing digital visualization of glass slides, facilitating the review and interpretation of surgical pathology in a digital format, thus modernizing and streamlining pathology workflows.
Intended Use
The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system intended for in vitro diagnostic use as an aid to pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is not intended for frozen section, cytology, or non-FFPE hematopathology specimens.
Technology
The PIPS 5.1 system consists of scanner subsystems (Ultra Fast Scanner and various Pathology Scanner SG models), an Image Management System (IMS 4.2), and clinical display components (PP27QHD, Beacon C411W, or Barco MDCC-4430). It creates and displays digital images that replicate conventional light microscopy visualization. It does not include any automated image analysis or diagnostic algorithms.
Performance
Non-clinical performance testing was conducted on the new clinical display to verify compliance with international and FDA-recognized standards, including IEC 60601-1, IEC 60601-1-6, IEC 62471, and ISO 14971. Tests verified image quality factors such as spatial resolution, pixel defects, artifacts, luminance, color calibration, and stability, demonstrating substantial equivalence to the predicate device. No clinical data was required as equivalence was established through intended use, technological characteristics, and non-clinical testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/17/2024
2 months - 2
FDA Approval
3/6/2025
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