FDA-cleared K252421

JLK-NCCT

JLK, Inc.

Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...

Modality
CT/CTA
Anatomy
Brain and intracranial vessels: intracranial hemorrhage and LVO involving ICA, MCA-M1, and MCA-M2
Decision
2026-03-24
FDA-cleared K243611

JLK-SDH

JLK, Inc.

JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile...

Modality
CT/CTA
Anatomy
Head
Decision
2025-03-03
FDA-cleared K241480

JBS-LVO

JLK, Inc.

Notification-only parallel workflow analysis of acute brain CTA to identify suspected large-vessel occlusion in the terminal ICA or MCA-M1 and notify a neurovascular specialist...

Modality
CT/CTA
Anatomy
Brain; terminal intracranial ICA and MCA-M1 vessels
Decision
2024-09-27
FDA-cleared K233196

Medihub Prostate

JLK Inc.

Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related...

Modality
MRI
Anatomy
Prostate
Decision
2024-06-21