510(k) · Cleared
ClearedVirasight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virasoft Corporation · PSY Whole Slide Imaging System
Cleared on Jul 17, 2026 as substantially equivalent to K213883 (Hamamatsu Photonics K.K., 2022) and 1 other predicate after a 387-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- Jul 17, 2026
- Review
- 387 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN160056 (2017). 4 ancestors in all. 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 backK190332 Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019
- 1 generation backK232202 Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024
- This deviceK251952 VirasightVirasoft Corporation · 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 | K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019 | — |
| −1 | K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024 | — |
| 0 (this device) | K251952 | Virasight | Virasoft Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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? (2)
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…thology Image Viewing and Management Software PREDICATE DEVICES Proprietary Name: NanoZoomer S360MD Slide scanner system Submission Number: K213883 Proprietary Name: Aperio GT 450 DX Submission Number: K232202 INDICATIONS FOR USE ViraSight is a w… | 2022 |
| * | K232202 | Aperio GT 450 DXSummary page 5…NanoZoomer S360MD Slide scanner system Submission Number: K213883 Proprietary Name: Aperio GT 450 DX Submission Number: K232202 INDICATIONS FOR USE ViraSight is a web-based software-only device intended to aid pathologists in the viewing and management of… | 2024 |
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 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 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. 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?
ViraSight is a web-based software-only device intended to aid pathologists in the viewing and management of digital
images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. It is an aid to the
pathologist to review these digital images for the purposes of pathology primary diagnosis.
ViraSight is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the
interpretation of images using ViraSight.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251952: Virasight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251952
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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