NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
Hamamatsu Photonics K.K. · K253606
FDA-authorized Predetermined Change Control Plan
- Company
- Hamamatsu Photonics K.K.
- 510(k)/De Novo #
- K253606
- Decision date
- 2026-07-15
- Panel
- Pathology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Compatibility expansion
- Monitoring commitment
- Not stated
What this PCCP covers. Permits compatibility expansion to additional hardware
Other PCCPs from Hamamatsu Photonics K.K.
Other Pathology PCCPs
- K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K.2026-07-22Non-AICompatibility expansion
- K254115ArteraAI BreastArtera, Inc.2026-05-04AI/SaMDModel update
- K243449INFINITT DPSInfinitt Healthcare Co., Ltd.2025-12-09Non-AIUnknown
- K252762HALO AP DxIndica Labs, LLC2025-11-25Non-AICompatibility expansion
- DEN240068ArteraAI ProstateArtera, Inc.2025-07-31AI/SaMDCompatibility expansion
- K243391AISight DxPathAI, Inc.2025-06-26Non-AICompatibility expansion
Want the monitoring teardown?
We read the PCCP for NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.