Clearance Summary
NanoZoomer S540MD Slide Scanner System received FDA 510(k) clearance under submission number K260964, sponsored by Hamamatsu Photonics K.K.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2026-07-22.
- Submission: K260964
- Applicant / Sponsor: Hamamatsu Photonics K.K.
- Clearance pathway: Abbreviated
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2026-07-22
Classification & Regulation
This clearance is catalogued under FDA product code PSY and 21 CFR 864.3700, within the Pathology review panel as a Class II device.