Cleared Abbreviated

K233027 - NanoZoomer S360MD Slide scanner system (FDA 510(k) Clearance)

Class II Pathology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K233027 · Hamamatsu Photonics K.K. · Pathology device
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Optimized for regulatory review, auditing and printing
Dec 2023
Decision
88d
Days
Class 2
Risk

K233027 is an FDA 510(k) clearance for the NanoZoomer S360MD 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 December 22, 2023 after a review of 88 days - a notably fast clearance 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

Submission Details

510(k) Number K233027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date December 22, 2023
Days to Decision 88 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
11d slower than avg
Panel avg: 77d · This submission: 88d
Pathway characteristics
Standards-based clearance path. PCCP authorized - AI/SaMD pathway.

Device Classification

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 18
Devices cleared under the same product code (PSY) and FDA review panel - the closest regulatory comparables to K233027.
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Philips IntelliSite Pathology Solution 5.1
K233204 · Philips Medical Systems Nederland B.V. · Jun 2024