510(k) · Cleared
Recalled · Class II · 2023NanoZoomer 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 Sep 27, 2022 as substantially equivalent to DEN160056 (Philips Medical Systems Nederland B.V., 2017) after a 288-day review. Its family tree reaches back 1 generation to 2017. 14 later devices descend from it. It has been recalled once.
- Decided
- Sep 27, 2022
- Review
- 288 days
- Class
- Class II
- Product code
- PSY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160056 (2017). 14 later devices descend from it, 6 citing it directly.
- Root · 1 generation backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- This deviceK213883 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2022
- Descendant · cites it directly · 7 of its ownK233027 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2023
- Descendant · cites it directly · 1 of its ownK230839 Concentriq DxProscia, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261380 Concentriq AP-DxProscia, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260964 NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K. · 2026
- Descendant · cites it directly · 0 of its ownK251952 VirasightVirasoft Corporation · 2026
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K233027NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2023 · cites it directly7descendants
- K230839Concentriq DxProscia, Inc. · 2024 · cites it directly1descendant
- K261380Concentriq AP-DxProscia, Inc. · 2026 · 2 generations on0descendants
- K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K. · 2026 · 2 generations on0descendants
- K251952VirasightVirasoft Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| 0 (this device) | K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022 | — |
| +1 | K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023 | — |
| +1 | K230839 | Concentriq Dx | Proscia, Inc. | 2024 | — |
| +2 | K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026 | — |
| +2 | K260964 | NanoZoomer S540MD Slide Scanner System | Hamamatsu Photonics K.K. | 2026 | — |
| +1 | K251952 | Virasight | Virasoft Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | DEN160056 | Philips IntelliSite Pathology SolutionSummary page 4…LASSIFICATION NAME: Whole Slide Imaging System REVIEW PANEL: 21 C.F.R. § 864.3700 PRODUCT CODE: PSY PREDICATE DEVICE(S): Philips IntelliSite Pathology Solution (PIPS) (DEN160056) 1 DEVICE DESCRIPTION: The NanoZoomer S360MD Slide scanner system is… | 2017 |
What descends from it? (14)
See all 146 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2023 | Class II | Z-2280-2023 | Software design | If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PSY devicesPSY Whole Slide Imaging System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 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 (138 words)
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 the JVC Kenwood JD-C240BNO1A display. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213883: 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/K213883
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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