510(k) · Cleared
ClearedRapid Aortic Measurements
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 23, 2025 as substantially equivalent to K243350 (Ischemaview, Inc., 2025) after an 88-day review. Its family tree reaches back 16 generations to 1990.
- Decided
- Sep 23, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K896095 (1990). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 12 generations between
- 3 generations backK213165 RapidIschemaview, Inc. · 2022
- 2 generations backK233582 RapidIschemaview, Inc. · 2024
- 1 generation backK243350 Rapid Neuro3DIschemaview, Inc. · 2025
- This deviceK251987 Rapid Aortic MeasurementsIschemaview, Inc. · 2025
Show all 16 generations
- Root · 16 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 15 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 14 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 13 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 12 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 11 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 10 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 9 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 8 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 7 generations backK120196 Olea SphereOlea Medical · 2012
- 6 generations backK121447 Ischema View RapidIschemaview, Inc. · 2013
- 5 generations backK172477 iSchemaView RAPIDIschemaview, Inc. · 2018
- 4 generations backK182130 iSchemaView RAPIDIschemaview, Inc. · 2018
- 3 generations backK213165 RapidIschemaview, Inc. · 2022
- 2 generations backK233582 RapidIschemaview, Inc. · 2024
- 1 generation backK243350 Rapid Neuro3DIschemaview, Inc. · 2025
- This deviceK251987 Rapid Aortic MeasurementsIschemaview, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −15 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −14 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −13 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −12 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −11 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −10 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −9 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −8 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −7 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| −6 | K121447 | Ischema View Rapid | Ischemaview, Inc. | 2013 | — |
| −5 | K172477 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −4 | K182130 | iSchemaView RAPID | Ischemaview, Inc. | 2018 | — |
| −3 | K213165 | Rapid | Ischemaview, Inc. | 2022 | — |
| −2 | K233582 | Rapid | Ischemaview, Inc. | 2024 | — |
| −1 | K243350 | Rapid Neuro3D | Ischemaview, Inc. | 2025 | — |
| 0 (this device) | K251987 | Rapid Aortic Measurements | Ischemaview, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K243350 | Rapid Neuro3DSummary page 5…Predicate Devices: iSchemaView’s Rapid Aortic Measurements is claimed to be substantially equivalent to the following legally marketed predicate device: Rapid Neuro3D (K243350). Device Description: Rapid Aortic Measurements (AM) is a Software as a Medical Device (SaMD) image processing module and is par… | 2025 |
| † | K223396 | Rapid RV/LV | 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 35 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 22 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. 2025, 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?
Rapid Aortic Measurements (AM) is an image analysis and measurement device to evaluate aortic and iliac arteries in contrast enhanced and non-contrast CT imaging datasets acquired of the chest, abdomen, and/or pelvis. The module segments the aorta, iliacs, and major branching vessels and provides 2D and 3D visualizations of the segmented vessels. Outputs of the device include: Centerline measurements of the aorta and iliacs, Aortic Zone Measurements…
Read the full statement (317 words)
Rapid Aortic Measurements (AM) is an image analysis and measurement device to evaluate aortic and iliac arteries in contrast enhanced and non-contrast CT imaging datasets acquired of the chest, abdomen, and/or pelvis. The module segments the aorta, iliacs, and major branching vessels and provides 2D and 3D visualizations of the segmented vessels.
Outputs of the device include: Centerline measurements of the aorta and iliacs, Aortic Zone Measurements (Maximum Oblique Diameter), Fixed Measurements of the aorta and left and right iliacs, 3D Volume Renderings, Rotations, Curved Planar Reformations (CPRs) of the isolated left and right iliacs, aortic oblique Multiplanar Reconstructions (MPRs), and Longitudinal Tracking visualizations.
Rapid Aortic Measurements is an aid to physician decision making. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment.
Rapid Aortic Measurements is indicated for adults.
Precautions/Exclusions:
o Series containing excessive patient motion or metal implants may impact module output quality.
o The AM module will not process series that meet the following module exclusion criteria:
* Series acquired w/cone-beam CT scanners (c-arm CT)
* Series that are non-axial or axial oblique greater than 5 degrees
* Series containing improperly ordered or missing slices where the gap is larger than 3 times the median inter-slice distance (e.g., as a result of manual correction by an imaging technician)
* Series with less than 3cm of target anatomical zones (e.g. aorta or right/left iliac artery)
* NCCT, CECT, CTA, or CTPA datasets with:
1) in-plane X and Y FOV < 160mm
2) Z FOV (cranio-caudal transverse anatomical coverage) < 144 mm.
3) in-plane pixel spacing (X & Y resolution) < 0.3 mm or > 1.0 mm.
4) inter-slice distance of < 0.3 mm or > 3 mm.
5) slice thickness > 3 mm.
6) data acquired at x-ray tube voltage < 70kVp or > 150kVp, including single energy, dual energy, or virtual monochromatic datasets
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251987: Rapid Aortic Measurements.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251987
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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