510(k) · Cleared
ClearedRapid Platform (R6.7)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ischemaview, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 21, 2026 as substantially equivalent to K233512 (Ischemaview, Inc., 2024) after a 147-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Sep 21, 2026
- Review
- 147 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K896095 (1990). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations between
- 3 generations backK182130 iSchemaView RAPIDIschemaview, Inc. · 2018
- 2 generations backK213165 RapidIschemaview, Inc. · 2022
- 1 generation backK233512 Rapid (6.0)Ischemaview, Inc. · 2024
- This deviceK261368 Rapid Platform (R6.7)Ischemaview, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 14 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 13 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 12 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 11 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 10 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 9 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 8 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 7 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 6 generations backK120196 Olea SphereOlea Medical · 2012
- 5 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 4 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 3 generations backK182130 iSchemaView RAPIDIschemaview, Inc. · 2018
- 2 generations backK213165 RapidIschemaview, Inc. · 2022
- 1 generation backK233512 Rapid (6.0)Ischemaview, Inc. · 2024
- This deviceK261368 Rapid Platform (R6.7)Ischemaview, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −14 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −13 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −12 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −11 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −10 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −9 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −8 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −7 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −6 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −5 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| −4 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −3 | K182130 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −2 | K213165 | Rapid | Ischemaview, Inc. | 2022 | — |
| −1 | K233512 | Rapid (6.0) | Ischemaview, Inc. | 2024 | — |
| 0 (this device) | K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K233512 | Rapid (6.0)Summary page 5…redicate Devices: The iSchemaView Rapid is claimed to be substantially equivalent to the following legally marketed predicate devices: Primary: iSchemaView Rapid (K233512) Previous Related FDA Submission: iSchemaView Rapid (K121447) – Initial Rapid Clearance iSchemaView Rapid (K213165) – Update Clea… | 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 36 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 21 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
iSchemaView's Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices. The iSchemaView Rapid provides both viewing and…
Read the full statement (304 words)
iSchemaView's Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices.
The iSchemaView Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT/CBCT Perfusion (CTP/CBCTP), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT).
The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue.
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion -weighted MRI data.
The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Rapid CT-Perfusion and Rapid MR-Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery)
Instructions for the use of contrast agents for this indication can be found in Appendix A of the User’s Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling.
In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions.
Contraindications/Exclusions:
* Bolus Quality: absent or inadequate bolus.
* Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate
* Presence of hemorrhage
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/K261368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261368: Rapid Platform (R6.7).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261368
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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