Pathpresenter Corporation · Class II · Cleared Jun 20, 2025
| K-number | K250968 |
| Device name | PathPresenter Clinical Viewer |
| Applicant | Pathpresenter Corporation |
| Product code | QKQ |
| Device class | Class II |
| Decision date | Jun 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 864.3700 |
PathPresenter Clinical Viewer is a web-based software application for viewing and managing whole slide images from scanned glass slides of formalin-fixed, paraffin-embedded (FFPE) tissue. It aids pathologists in reviewing digital images and rendering primary diagnoses, with functions including zooming, panning, annotating, and measuring distances and areas in images.
Key differences from the predicate (NanoZoomer S360MD) include: PathPresenter is internet browser-based (Chrome/Edge) whereas the predicate is desktop software; PathPresenter is a standalone viewer while the predicate is an integrated scanning and viewing system. Both use identical NDPI image formats, perform the same image manipulation functions (panning, zooming, annotation, measurement), and are designed for FFPE tissue specimens with equivalent clinical indications.
Not stated in this summary.
Substantial equivalence is supported by: (1) pixelwise color comparison testing across 180 image pairs from 30 FFPE slides demonstrating equivalence to within 3 CIEDE2000 units on both browsers; (2) turnaround time benchmarks showing acceptable performance for opening, zooming, and panning operations; (3) measurement accuracy validation confirming zero error in distance and area tools across magnification levels; and (4) human factors study demonstrating pathologists can perform critical tasks without use errors. These nonclinical tests establish that PathPresenter generates equivalent diagnostic images and functionality to the predicate despite architectural differences (browser-based vs. desktop).
View the full FDA submission: accessdata.fda.gov