510(k) · Cleared
ClearedHALO AP Dx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Indica Labs, Inc. · PSY Whole Slide Imaging System
Cleared on May 7, 2024 as substantially equivalent to K213883 (Hamamatsu Photonics K.K., 2022) after a 237-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- May 7, 2024
- Review
- 237 days
- Class
- Class II
- Product code
- PSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160056 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 4…Predicate Manufacturer: Hamamatsu Photonics K.K. Predicate Trade Name: NanoZoomer S360MD Slide scanner system Predicate 510(k): K213883 No reference devices were used in this submission. 4. Device Description HALO AP Dx, version 2.1 is a browser-based s… | 2022 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 2 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. 2024, 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?
For In Vitro Diagnostic Use HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to…
Read the full statement (117 words)
For In Vitro Diagnostic Use
HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx 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 quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. HALO AP Dx is intended for use with the Hamamatsu NanoZoomer S360MD Slide scanner and the JVC Kenwood JD-C240BN01A display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232833: HALO AP Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232833
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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