510(k) · Cleared
ClearedNanoZoomer 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 Dec 22, 2023 as substantially equivalent to K213883 (Hamamatsu Photonics K.K., 2022) after an 88-day review. Its family tree reaches back 2 generations to 2017. 7 later devices descend from it.
- Decided
- Dec 22, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160056 (2017). 7 later devices descend from it, 7 citing it directly.
- Root · 2 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 1 generation backK213883 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2022 · Recalled
- This deviceK233027 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2023
- Descendant · cites it directly · 0 of its ownK260964 NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K. · 2026
- Descendant · cites it directly · 0 of its ownK253606 NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide…Hamamatsu Photonics K.K. · 2026
- Descendant · cites it directly · 0 of its ownK243449 Infinitt DPSInfinitt Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK252762 HALO AP DxIndica Labs, LLC · 2025
- Descendant · cites it directly · 0 of its ownK243391 AISight DxPathAI, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K. · 2026 · cites it directly0descendants
- K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2026 · cites it directly0descendants
- K243449Infinitt DPSInfinitt Healthcare Co., Ltd. · 2025 · cites it directly0descendants
- K252762HALO AP DxIndica Labs, LLC · 2025 · cites it directly0descendants
- K243391AISight DxPathAI, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −1 | K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022 | 1 |
| 0 (this device) | K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023 | — |
| +1 | K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | 2026 | — |
| +1 | K253606 | NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2026 | — |
| +1 | K243449 | Infinitt DPS | Infinitt Healthcare Co., Ltd. | 2025 | — |
| +1 | K252762 | HALO AP Dx | Indica Labs, LLC | 2025 | — |
| +1 | K243391 | AISight Dx | PathAI, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
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 |
|---|---|---|---|
| * | K213883 | NanoZoomer S360MD Slide scanner systemSummary page 5…PSY Review Panel: 88 – Pathology PREDICATE DEVICE Proprietary Name: NanoZoomer S360MD Slide scanner system Submission Number: K213883 Page 1 PURPOSE OF THE SUBMISSION The purpose of this Abbreviate… | 2022 |
| † | K203364 | MDPC-8127 | 2021 |
What descends from it? (7)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K260964 (Hamamatsu Photonics K.K., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K213883.
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The NanoZoomer S360MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. 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…
Read the full statement (170 words)
The NanoZoomer S360MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. 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.
The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and a compatible display that has been 510(k) cleared for use with the NanoZoomer system or a 510(k)-cleared display that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional compatible displays. 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. 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/K233027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233027: NanoZoomer S360MD Slide scanner system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233027
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026