| K-number | K242244 |
| Device name | Viewer+ |
| Applicant | Lumea, Inc. |
| Product code | QKQ |
| Device class | Class II |
| Decision date | Mar 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 864.3700 |
Viewer+ is a web-based software device for viewing and managing digital images of surgical pathology slides scanned from formalin-fixed paraffin-embedded (FFPE) tissue. It aids pathologists in reviewing, interpreting, and managing these images for primary diagnosis, and is intended for use with the Hamamatsu NanoZoomer S360MD scanner and BARCO MDPC-8127 display.
Viewer+ is an internet browser-based application, whereas the predicate NanoZoomer S360MD system is a PC-based installed application. Both perform continuous panning and zooming, annotations, distance/area measurements, and image export. Viewer+ includes workload organization and patient data viewing functions; the predicate includes discrete Z-axis displacement and visited-area tracking instead.
FDA guidance documents: 'Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)' and 'Applying Human Factors and Usability Engineering to Medical Devices (2016)'.
Viewer+ demonstrates substantial equivalence because it shares the same intended use (viewing FFPE surgical pathology slides for primary diagnosis), same specimen type, same diagnostic image file format (Hamamatsu NDPI), and same principles of operation as the predicate. Performance testing showed pixel-wise identical image output (95th percentile differences <3 CIEDE2000), adequate turnaround times, accurate measurements, and safe usability. The difference in software architecture (browser-based vs. PC-installed) does not raise new safety or effectiveness concerns since both accomplish identical image viewing and interpretation functions.
View the full FDA submission: accessdata.fda.gov