510(k) · Cleared
ClearedNanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamamatsu Photonics K.K. · PSY Whole Slide Imaging System
Cleared on Jul 15, 2026 as substantially equivalent to K233027 (Hamamatsu Photonics K.K., 2023) after a 239-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- Jul 15, 2026
- Review
- 239 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN160056 (2017). No later device cites it as a predicate yet.
- Root · 3 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 2 generations backK213883 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2022 · Recalled
- 1 generation backK233027 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2023
- This deviceK253606 NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide…Hamamatsu Photonics K.K. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −2 | K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022 | 1 |
| −1 | K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023 | — |
| 0 (this device) | K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PSY device
- #1 K232202 Aperio GT 450 DXscore 34.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233027 | NanoZoomer S360MD Slide scanner systemSummary page 5…ory Classification: Class II Product Code: PSY Review Panel: 88 – Pathology PREDICATE DEVICE Proprietary Name: NanoZoomer S360MD Slide scanner system Submission Number: K233027 K253606 PURPOSE OF THE SUBMISSION The purpose of this Abbre… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 6 other devices also cite its predicate K233027.
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSY
265in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSY
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSY
1in 2023
MAUDE reports naming product code PSY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 9 | 265 | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 4 | 253 | 1 | — |
What is it indicated for?
NanoZoomer S20MD Slide scanner system: The NanoZoomer S20MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. The NanoZoomer System is intended for in vitro diagnostic use as an aid to the pathologist to…
Read the full statement (252 words)
NanoZoomer S20MD Slide scanner system:
The NanoZoomer S20MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. The NanoZoomer System is intended for in vitro diagnostic use 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 NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using NanoZoomer System.
NanoZoomer S360MD Slide scanner system:
The NanoZoomer S360MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. The NanoZoomer System is intended for in vitro diagnostic use 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 NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using NanoZoomer System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253606 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253606: NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253606
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026