FDA-cleared K243363
JLK-ICH
JLK, Inc.
Notification-only triage of suspected intracranial hemorrhage on non-contrast head CT
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-01-03
Use case
Stroke and ICH triage radiology AI tools
A buyer-oriented shortlist for stroke and ich triage. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-cleared K233582
Rapid
iSchema View Inc.
Rapid is image-viewing, processing, and analysis software for DICOM CT, CT perfusion, CT angiography, C-arm CT perfusion, and MRI data, including perfusion maps and acute-stroke...
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Brain, cerebral vasculature, and perfusion regions
- Decision
- 2024-04-22
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 K213165
Rapid
iSchema View Inc.
Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained...
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Brain
- Decision
- 2022-02-08
FDA-cleared K212116
VBrain-OAR
Vysioneer Inc.
VBrain-OAR provides the cleared image-processing and organ-at-risk contouring support described in K212116 for brain radiotherapy planning, with all contours requiring...
- Modality
- Radiotherapy Planning Imaging
- Anatomy
- Brain and intracranial organs at risk
- Decision
- 2021-10-12
FDA-cleared K203508
BriefCase
Aidoc Medical, Ltd.
BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...
- Modality
- CT/CTA
- Anatomy
- Adult head, brain, cervical spine, pulmonary arteries, and thorax
- Decision
- 2020-12-29
FDA-cleared K200873
HALO
NICo-Lab B.V.
HALO analyzes contrast-enhanced brain CTA in the acute setting for suspected anterior-circulation large-vessel occlusion and provides notification support for emergency stroke...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-11-20
FDA-cleared K200750
Neuro.Al Algorithm
TeraRecon, Inc.
Neuro.Al Algorithm processes static, functional, dynamic, and derived CT or MR images to support brain perfusion analysis, tissue blood-volume and parametric-map review,...
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Brain and intracranial perfusion regions
- Decision
- 2020-11-06
FDA-cleared K200855
CINA
AVICENNA.AI
CINA analyzes nonenhanced head CT for suspected intracranial hemorrhage and head CTA for suspected large-vessel occlusion for computer-aided triage and notification in parallel...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2020-06-24
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
FDA-cleared K182177
Accipiolx
MaxQ-Al Ltd.
Accipiolx prioritizes adult noncontrast head CT studies for cases with acute intracranial hemorrhage by sending studies from PACS to an analysis engine and returning case-level...
- Modality
- CT/CTA
- Anatomy
- Adult head and brain; acute intracranial hemorrhage
- Decision
- 2018-10-26
FDA-cleared K180647
BriefCase
Aidoc Medical, Ltd.
BriefCase provides computer-assisted triage and notification for suspected intracranial hemorrhage on noncontrast head CT and or large-vessel occlusion on head CTA in parallel...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2018-08-01