510(k) · Cleared
ClearedRapid Obstructive Hydrocephalus, Rapid OH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ischemaview, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Sep 4, 2025 as substantially equivalent to K232436 (Ischemaview, Inc., 2023) after a 108-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Sep 4, 2025
- Review
- 108 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 4 generations backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 3 generations backK193087 Rapid ICHIschemaview Incorporated · 2020
- 2 generations backK221456 Rapid ICHIschemaview, Inc. · 2022
- 1 generation backK232436 Rapid SDHIschemaview, Inc. · 2023
- This deviceK251533 Rapid Obstructive Hydrocephalus, Rapid OHIschemaview, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −4 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −3 | K193087 | Rapid ICH | Ischemaview Incorporated | 2020 | — |
| −2 | K221456 | Rapid ICH | Ischemaview, Inc. | 2022 | — |
| −1 | K232436 | Rapid SDH | Ischemaview, Inc. | 2023 | — |
| 0 (this device) | K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Ischemaview, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K232436 | Rapid SDHSummary page 5…evices Panel: Predicate Devices: The iSchemaview Rapid OH Analysis Module is claimed to be substantially equivalent to the legally marketed predicate, Rapid SDH (K232436). Device Description: Rapid OH software device is a radiological computer-aided triage and notification software device using AI… | 2023 |
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 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
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. 2025, 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?
Rapid OH is a radiological computer aided triage and notification software indicated for suspicion of Obstructive Hydrocephalus (OH) in non-enhanced CT head images of adult patients. The device is intended to assist trained clinicians in workflow prioritization triage by providing notification of suspected findings in head CT images. Rapid OH uses an artificial intelligence algorithm to analyze images and highlight cases with suspected OH on a server or…
Read the full statement (242 words)
Rapid OH is a radiological computer aided triage and notification software indicated for suspicion of Obstructive Hydrocephalus (OH) in non-enhanced CT head images of adult patients. The device is intended to assist trained clinicians in workflow prioritization triage by providing notification of suspected findings in head CT images.
Rapid OH uses an artificial intelligence algorithm to analyze images and highlight cases with suspected OH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected OH findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of Rapid OH are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Contraindications/Limitations/Exclusions:
• Rapid OH is intended for use for adult patients.
• Input data image series containing excessive patient motion or metal implants may impact module analysis accuracy, robustness and quality.
• Ventriculoperitoneal shunts are contraindicated
Exclusions:
• Series with missing slices or improperly ordered slices
• data acquired at x-ray tube voltage < 100kVp or > 140kVp.
• data not representing human head or head/neck anatomical regions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251533: Rapid Obstructive Hydrocephalus, Rapid OH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251533
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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