FDA-cleared K251987

Rapid Aortic Measurements

iSchemaView, Inc.

Aortic and iliac artery segmentation, visualization, measurement, and longitudinal tracking as adjunctive physician decision support.

Modality
CT/CTA
Anatomy
Aorta, iliac arteries, and major branching vessels in the chest, abdomen, and/or pelvis
Decision
2025-09-23
FDA-cleared K243378

Rapid MLS

iSchemaview Inc.

Brain midline-shift measurement on adult non-contrast CT

Modality
CT/CTA
Anatomy
Brain
Decision
2025-05-28
FDA-cleared K243350

Rapid Neuro3D

iSchemaView, Inc.

Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations,...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-22
FDA-cleared K232156

Rapid ASPECTS (v3)

iSchemaView, Inc.

Adjunct assessment of early ischemic brain tissue injury and extent of disease in adult ischemic-stroke diagnostic imaging workup, typically within 24 hours of last known well

Modality
CT/CTA
Anatomy
Brain/head ASPECTS regions
Decision
2024-01-19
FDA-cleared K233512

Rapid (6.0)

iSchemaView, Inc.

Rapid Platform v6.0 is image-processing software for trained professionals that views, processes, and analyzes DICOM images from CT and MRI. It supports functional and dynamic...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain and intracranial vessels represented in CT perfusion, CTA, and MRI; tissue perfusion, diffusion, and contrast dynamics
Decision
2024-01-16
FDA-cleared K232436

Rapid SDH

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2023-10-25
FDA-cleared K222884

Rapid NCCT Stroke

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2023-03-02
FDA-cleared K221456

Rapid ICH

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-09-12
FDA-cleared K221248

Rapid LVO

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-05-31
FDA-cleared K200941

Rapid LVO

iSchemaView Inc.

Notification-only triage of adult head CTA for suspected large-vessel occlusion; results do not replace diagnostic interpretation.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-07-09
FDA-cleared K200760

Rapid ASPECTS

iSchemaView Inc.

Adjunct evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours

Modality
CT/CTA
Anatomy
Brain/head ASPECTS regions
Decision
2020-06-26
FDA-cleared K182130

iSchemaView RAPID

iSchemaView, Inc.

iSchemaView RAPID processes CT perfusion, CTA, and MR studies to visualize and analyze diffusion and perfusion, including tissue blood-volume maps, and supports physician...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain, intracranial vasculature, and perfusion regions
Decision
2018-12-27