FDA clears NanoZoomer S360MD slide scanner system

Oct. 10, 2022—Hamamatsu Photonics announced that the FDA granted 510(k) clearance to market the NanoZoomer S360MD high-throughput, automated slide scanner system for primary diagnostic use. The system is intended for in vitro diagnostic use to aid pathologists in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed, paraffin-embedded tissue.

The NanoZoomer system comprises the NanoZoomer S360MD slide scanner, NZViewMD software, and the JVC Kenwood JD-C240BN01A display. It can digitize 360 slides at a time scanning at 40x magnification and can scan 82 slides per hour at 40x mode when scanning an area of 15 x 15 mm tissue with five focal points. Users scan in semi- or fully automatic mode.