NanoZoomer S540MD Slide Scanner System
FDA 510(k) clearance K260964 · decided 2026-07-22
Clearance details
- K-number
- K260964
- Device name
- NanoZoomer S540MD Slide Scanner System
- Applicant
- Hamamatsu Photonics K.K.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-23
- Decision date
- 2026-07-22
- Days to decision
- 121 days
- Clearance type
- Abbreviated
- Product code
- PSY
- Device class
- 2
- Regulation number
- 864.3700
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Hamamatsu City, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.