Cleared Abbreviated

K253606 - NanoZoomer S20MD Slide scanner system

Also marketed or referenced as:
NanoZoomer S360MD Slide scanner system

K253606 is an FDA 510(k) clearance for NanoZoomer S20MD Slide scanner system, manufactured by Hamamatsu Photonics K.K.. The device is a Class 2 Pathology device with product code PSY cleared through the Abbreviated 510(k) pathway after a 239-day FDA review.

K253606 · Hamamatsu Photonics K.K. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
239d
Days
Class 2
Risk

K253606 is an FDA 510(k) clearance for the NanoZoomer S20MD Slide scanner system. Classified as Whole Slide Imaging System (product code PSY), Class II - Special Controls.

Submitted by Hamamatsu Photonics K.K. (Hamamatsu City, JP). The FDA issued a Cleared decision on July 15, 2026 after a review of 239 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3700 - the FDA pathology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hamamatsu Photonics K.K. devices

FDA 510(k) Submission Details - K253606

510(k) Number K253606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2025
Decision Date July 15, 2026
Days to Decision 239 days
Submission Type Abbreviated
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 78d · This submission: 239d
Pathway characteristics
Standards-based clearance path. PCCP authorized - AI/SaMD pathway.

PSY Device Classification - Class 2, Special Controls

Product Code PSY Whole Slide Imaging System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3700
Definition The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Consultant

Hyman, Phelps & McNamara, P.C.
Adrienne Lenz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PSY Whole Slide Imaging System

All 22
Devices cleared under the same product code (PSY) and FDA review panel - the closest regulatory comparables to K253606.
Aperio GT 450 DX
K253554 · Leica Biosystems Imaging, Inc. · Aug 2026
NanoZoomer S540MD Slide Scanner System
K260964 · Hamamatsu Photonics K.K. · Jul 2026
Virasight
K251952 · Virasoft Corporation · Jul 2026
Philips IntelliSite Pathology Solution 5.1
K243871 · Philips Medical Systems Nederland B.V. · Mar 2025
E1000 Dx Digital Pathology Solution
K241717 · Shandon Diagnostics Limited · Feb 2025
Roche Digital Pathology Dx
K242783 · Ventana Medical Systems, Inc. · Dec 2024