Philips IntelliSite Pathology Solution 5.1
Philips Medical Systems Nederland B.V.The Philips IntelliSite Pathology Solution 5.1 is a digital pathology system that automates scanning, managing, and viewing of glass pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It aids pathologists by providing high-resolution digital images of tissue slides for diagnostic review, enhancing the workflow for interpretation compared to traditional microscopy.
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 use with frozen section, cytology, or non-FFPE hematopathology specimens.
Technology
The system comprises various scanner models (Ultra Fast Scanner (UFS), Pathology Scanner SG20, SG60, SG300), an Image Management System (IMS 4.2), and clinical displays (PP27QHD or Beacon C411W). It creates digital images from glass slides suitable for manual visualization by microscopy, with no automated analysis capabilities. A new optional display, Beacon C411W, has similar performance and characteristics as the predicate device's display.
Performance
Non-clinical performance testing of the new display demonstrated compliance with international and FDA-recognized standards including IEC 60601 series, IEC 62471, and ISO 14971. Functional, safety, and integration testing showed the device with the new display is safe and effective and substantially equivalent to the predicate device. No clinical performance testing was required due to substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/20/2024
2 months - 2
FDA Approval
12/10/2024
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