510(k) · Cleared
ClearedRapid ASPECTS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ischemaview, Inc. · POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Cleared on Jun 26, 2020 as substantially equivalent to DEN170022 (Quantitative Insights, Inc., 2017) after a 94-day review. Its family tree reaches back 1 generation to 2017. 5 later devices descend from it.
- Decided
- Jun 26, 2020
- Review
- 94 days
- Class
- Class II
- Product code
- POK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170022 (2017). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN170022 QuantXQuantitative Insights, Inc. · 2017
- This deviceK200760 Rapid ASPECTSIschemaview, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK221564 Brainomix 360 e-ASPECTSBrainomix Limited · 2023
- Descendant · 2 generations on · 0 of its ownK250221 StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243294 Brainomix 360 e-ASPECTSBrainomix Limited · 2025
- Descendant · cites it directly · 0 of its ownK233342 Cina-AspectsAvicenna.Ai · 2024
- Descendant · cites it directly · 0 of its ownK232156 Rapid ASPECTS (v3)Ischemaview, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K221564Brainomix 360 e-ASPECTSBrainomix Limited · 2023 · cites it directly2descendants
- K250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025 · 2 generations on0descendants
- K243294Brainomix 360 e-ASPECTSBrainomix Limited · 2025 · 2 generations on0descendants
- K233342Cina-AspectsAvicenna.Ai · 2024 · cites it directly0descendants
- K232156Rapid ASPECTS (v3)Ischemaview, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170022 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| 0 (this device) | K200760 | Rapid ASPECTS | Ischemaview, Inc. | 2020 | — |
| +1 | K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2023 | — |
| +2 | K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | 2025 | — |
| +2 | K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2025 | — |
| +1 | K233342 | Cina-Aspects | Avicenna.Ai | 2024 | — |
| +1 | K232156 | Rapid ASPECTS (v3) | Ischemaview, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 POK? 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 POK device
- #1 K242342 Fetal EchoScanscore 16.8 · 9 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 |
|---|---|---|---|
| * | DEN170022 | QuantXSummary page 4…ices Panel: Predicate Devices: The iSchemaView Rapid is claimed to be substantially equivalent to the following legally marketed predicate device: QuantX (DEN170022) Device Description: Rapid ASPECTS Module Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the… | 2017 |
What descends from it? (5)
3 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?
How does its category compare?
All POK devicesPOK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · POK
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POK
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · POK
No recall names POK since 2007.
Adverse event reports per year · POK
1in 2021
MAUDE reports naming product code POK, 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 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 6 | 161 | 0 | 0 |
| 2025 | 5 | 119 | 0 | 0 |
| 2026 | 5 | 155 | 0 | — |
What is it indicated for?
Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of lnterest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then…
Read the full statement (283 words)
Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of lnterest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.
Limitations:
1. Rapid ASPECTS is not intended for primary interpretation of CT images, it is used to assist physician evaluation.
2. Rapid ASPECTS has been validated in patients with known MCA or ICA Occlusion prior to ASPECT scoring.
3. Use of the Rapid ASPECTS Module in clinical settings other than early brain ischemia (within 6 hours) caused by known ICA or MCA occlusions has not been tested.
4. Rapid ASPECTS has been validated and is intended to be used on GE Lightspeed VCT Scanners.
Contraindications/Exclusions/Cautions:
• Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
• Hemorrhagic Transformation, Hematoma
• Very thin or no Ventricles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200760 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200760: Rapid ASPECTS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200760
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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