510(k) · Cleared
ClearedAnnalise Enterprise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harrison-AI Medical Pty, Ltd. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Mar 3, 2026 as substantially equivalent to K222884 (Ischemaview, Inc., 2023) after a 95-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Mar 3, 2026
- Review
- 95 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 2 generations backK200855 CINAAvicenna.Ai · 2020
- 1 generation backK222884 Rapid NCCT StrokeIschemaview, Inc. · 2023
- This deviceK253818 Annalise EnterpriseHarrison-AI Medical Pty, Ltd. · 2026
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 QAS? 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 QAS device
- #1 K203508 BriefCasescore 25.5 · 4 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 |
|---|---|---|---|
| * | K222884 | Rapid NCCT StrokeSummary page 6…Class II Product Code QAS PREDICATE DEVICE Manufacturer Name iSchemaView, Inc. Device Name Rapid NCCT Stroke 510(k) reference K222884 Classification Name Radiological computer aided triage and notification software (21 CFR 892.2080) R… | 2023 |
| † | K220709 | BriefCase | 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 8 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K222884.
How does its category compare?
All QAS devicesQAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QAS
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAS
101in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAS
No recall names QAS since 2007.
Adverse event reports per year · QAS
No MAUDE report names QAS since 2007.
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 | 0 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 0 |
| 2019 | 5 | 111 | 0 | 0 |
| 2020 | 12 | 112 | 0 | 0 |
| 2021 | 5 | 86 | 0 | 0 |
| 2022 | 15 | 116 | 0 | 0 |
| 2023 | 11 | 98 | 0 | 0 |
| 2024 | 12 | 136 | 0 | 0 |
| 2025 | 15 | 101 | 0 | 0 |
| 2026 | 11 | 104 | 0 | — |
What is it indicated for?
Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings: • acute infarct* *See Additional Information, below. The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage. The device…
Read the full statement (381 words)
Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings:
• acute infarct*
*See Additional Information, below.
The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage.
The device is not intended to direct attention to specific portions of an image and only provides notification for suspected findings.
Its results are not intended:
• to be used on a standalone basis for clinical decision making
• to rule out specific findings, or otherwise preclude clinical assessment of non-contrast computed tomography brain
Intended modality
Annalise Enterprise identifies suspected findings in non-contrast brain CT studies.
Intended user
The device is intended to be used by trained clinicians who are qualified to interpret CTB studies as part of their scope of practice.
Intended patient population
The intended population is patients who are 22 years or older.
Additional information
The device includes acute infarct of the cerebral hemispheres or cerebellum, also including early signs of acute middle cerebral artery (MCA) infarct such as insular ribbon sign and disappearing basal ganglia sign.
The infarct must be a completed infarct (i.e. include an ischemic core of ≥5mL). The device also includes hyperdense artery in the anterior circulation but does not include lacunar infarcts, brainstem infarcts or venous infarcts.
The radiological device definition of acute infarct includes the following territories and regions:
• anterior cerebral artery (ACA)
• middle cerebral artery (MCA)
• posterior cerebral artery (PCA)
• cerebellum
• basilar artery occlusions
• watershed regions
Specificity may be reduced in the presence of infarcts of <5mL.
Caution:
All patients should get adequate care for their symptoms, including advanced imaging (e.g., CTA, CTP, MRI, etc.) and/or other appropriate care per standard clinical practice, irrespective of the device output.
The device is not intended to be a rule-out device and for cases that have been processed by the device, an absence of a notification for suspected acute infarct should not be viewed as indicating that acute infarct is excluded.
Limitations:
The device does not replace the need for advanced imaging in the stroke workup. It provides workflow prioritization and notification only.
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/K253818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253818: Annalise Enterprise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253818
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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